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| Lot Number W69234 |
| Device Problems
Unsealed Device Packaging (1444); Manufacturing, Packaging or Shipping Problem (2975)
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| Patient Problems
Pain (1994); Skin Tears (2516)
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Event Type
malfunction
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Manufacturer Narrative
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Sub-class: unidentifiable material in contact with product.Root cause analysis/identify: the most probable root cause of this event is equipment / mechanical failure.Equipment (rule-in) the non-woven materials that are stack-up over the cell pack of the thermacare neck shoulder and wrist product are glued by the m-line (assemble name) identified as 0-2 and 1-1.The (assembly name) glue head applicators 0-2 and its modules/nozzles are responsible to spray glue over the sca laminate located at the wrap body side.The sca laminate contains 3 components: the sms material, the skin contact adhesive and the release paper.The sca laminate (sms side) is attached to the carrier web (bottom film) after the glue application from (assembly name) 0-2.(assembly name) 1-1 sprays glue over the carrier web (over top film known as hna) to bond the sms material located at the wrap clothing side.The returned sample shows glue blobs between the sca laminate (sms side) and the cell pack located at the body side.It was determined by (investigator name) (wh) (lead investigator), (specialist name) (gw) (production technical specialist) and asa that these glue blobs came from (assembly name) 0-2.Work order number # was generated to replace the 0-2 glue module after the manufacturing of batch w69234.A defective nozzle module affects the glue spaying and can create glue blobs like the ones observed on the returned sample.This is the most probable cause of this incident.Asa reviewed the preventive maintenance (pm) for the (assembly name) (# - pm (assembly name) monthly check).There are instructions for nozzle and glue system inspection in a monthly basis.No changes are proposed for this pm.The glue nozzles require cleaning with wax bars to maintain the appropriate glue pattern.Sop-# "equipment cleaning, inspection and lubrication (cil) procedure" includes instructions to clean the m-line critical areas in each production shift and on an ongoing, as needed basis during the shift to e.
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Event Description
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It had a defect in the center, top of the pad which caused it to rub his skin and created a slight bit of pain.[pain], it had a defect in the center, top of the pad which caused it to rub his skin and created a slight bit of pain/something sharp dug into skin [skin discomfort], it was just a quick little scratch, it didn't break the skin [scratch], it had a defect in the center, top of the pad/the defect was ridged and somewhat sharp [device issue].Case narrative: this is a spontaneous report from a contactable consumer reporting for himself.A (b)(6)-year-old male patient started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number w69234, expiration date jan2021, upc number: (b)(4) (also reported as udi number), from (b)(6) 2019 at one wrap applied to skin once for slight muscle pain/ slight pain, also reported 1 per day for about a week for neck pain from an unknown date "as pain comes and goes".There was no relevant medical history.Concomitant medication included ongoing naproxen from (b)(6) 2019, as needed/periodically throughout the years.The patient had been using thermacare products for 10 to 12 years for various reasons, mostly lower back.He just purchased 3 pack neck pain therapy product from a (pharmacy name).It had a defect in the center, top of the pad which caused it to rub his skin and created a slight bit of pain in (b)(6) 2019.The defect was ridged and somewhat sharp.He immediately took it off and also noted it was not warming up.He inspected the other two and found one of them had never been sealed properly.He also inspected the packaging which he tore opened to use the first one-and found the same flaw which was probably why it did not heat.The third one also had a flaw on the "sealing" and was barely sealed up.The patient further reported that he opened the thermacare neck heat wrap, and ripped it open and put it on, and something sharp dug into his skin on (b)(6) 2019.It was just a quick little scratch, it didn't break the skin, so he took it off, it had a serious flaw, like the part had turned rigid and had a tear where it was like cardboard, or plastic, and it also wouldn't heat.He looked at the package again, and it was never sealed.The other 2 in the 3 pack, one had never been sealed, and the other was barely sealed, it had a tiny hole in it.There was something, maybe a chemical that probably made it rigid, he never experienced that.He was ok, but didn't know if there will be any long term effects or anything.When he felt the stick, the scratch, he almost immediately took it off and inspected it, and discontinued use of it.He didn't know if will continue using them, he assumed so, but he will inspect more carefully, as these were sealed in a box.He may or may not continue using them in general.Upon follow up on 11mar2019, the patient stated "have used your thermacare product for years and have never experience an issue.The product in this box were very inferior.The package containing this product was probably never sealed because the device would not heat.In addition, when i applied the device.I was stuck like a pin.By a defect in the device".On 20may2019, the patient reported "the wrap was broken and device would not heat- manufacturer defect".The patient was not hospitalization and did not received treatment due to all events.The action taken in response to the events for thermacare heatwrap was dose not changed.The outcome of the events was resolved on (b)(6) 2019.A sample of the product was available to be returned.The box was sealed and intact, the wraps had a manufacturer flaw.The patient considered the event "something sharp dug into his skin" was related to the use of the product.According to the product quality complaint group: sub-class: unidentifiable material in contact with product.Root cause analysis/identify: the most probable root cause of this event is equipment / mechanical failure.Equipment (rule-in) the non-woven materials that are stack-up over the cell pack of the thermacare neck shoulder and wrist product are glued by the m-line (assemble name) identified as 0-2 and 1-1.The (assembly name) glue head applicators 0-2 and its modules/nozzles are responsible to spray glue over the sca laminate located at the wrap body side.The sca laminate contains 3 components: the sms material, the skin contact adhesive and the release paper.The sca laminate (sms side) is attached to the carrier web (bottom film) after the glue application from (assembly name) 0-2.(assembly name) 1-1 sprays glue over the carrier web (over top film known as hna) to bond the sms material located at the wrap clothing side.The returned sample shows glue blobs between the sca laminate (sms side) and the cell pack located at the body side.It was determined by (investigator name) (wh) (lead investigator), (specialist name) (gw) (production technical specialist) and asa that these glue blobs came from (assembly name) 0-2.Work order number # was generated to replace the 0-2 glue module after the manufacturing of batch w69234.A defective nozzle module affects the glue spaying and can create glue blobs like the ones observed on the returned sample.This is the most probable cause of this incident.Asa reviewed the preventive maintenance (pm) for the (assembly name) (# - pm (assembly name) monthly check).There are instructions for nozzle and glue system inspection in a monthly basis.No changes are proposed for this pm.The glue nozzles require cleaning with wax bars to maintain the appropriate glue pattern.Sop-# "equipment cleaning, inspection and lubrication (cil) procedure" includes instructions to clean the m-line critical areas in each production shift and on an ongoing, as needed basis during the shift to ensure line runs effectively and produces good quality product.It includes the (assembly name).The current version of sop-# v11.0, effective date 27feb2019 the critical cils are highlighted in yellow indicating they have priority to be performed first during each manufacturing shift.The (assembly name) are included in the critical category.No changes are proposed for this procedure.There is an in-process quality inspection performed during production of finished product batches.The attribute inspection for major glue blobs/drips is a visual inspection of the wrap and it was conducted for batch w69234 every 10 minutes of uptime per spec-(b)(4) "neck shoulder wrist (swan) 8hr printed formula card", v.11.0 effective date 04aug2017.The review of the manufacturing attributes and variables inspections associated to batch w69234 indicates that all required in-process inspections were performed and all inspections criteria were met.There were no wrap attribute or variable defects recorded for batch w69234.Therefore, this incident is considered an isolated event.This is the first complaint for batch w69234 related to glue blobs between sca laminate (sms side) and the cell pack at the wrap body side.There are no other complaints related to this defect impacting other thermacare batches at this time.After the manufacturing of batch w69234, the frequency of the quality inspections (variable and physical attributes, product geometry) was increased from every 10 minutes to every 6 minutes for attributes and from every 20 minutes to every 18 minutes for variables.Therefore, the inspection to detect product defects like glue blobs are more extensive after the manufacturing of batch w69234.Sop-# "thermacare product attribute measurement" v1.0, effective date: 31jan2018 was created after the manufacturing of batch w69234.This procedure includes specific instructions of how to perform the different attribute checks.It includes instructions to identify and classify glue blobs according its appearance and size.Also, it describes how to identify gap or issues in the glue pattern.This procedure was created as standardized method to identify and classify defects in the product attribute.Therefore, the manufacturing technicians now are able to identify the glue blobs defects in a standardized way.Based on the information provided above, there are controls in place to detect the glue blobs observed in the returned samples.Some of them (like the increase of quality inspections frequency and the implementation of (b)(4)) were implemented after the manufacturing of batch w69234.No further actions are recommended.Training can be ruled out.The production operators and contingent employees involved in the heat pack maker process have been trained.Method can be ruled out.Sop-# "equipment cleaning, inspection and lubrication (cil) procedure" includes instructions to clean the m-line critical areas in each production shift.It includes the m-line (assembly name) cleaning procedure.Measurement can be ruled out.There is no measurement system related to this event.Material can be ruled out because it is not related to glue blobs issue.Environment was ruled as the root cause because the glue blobs defect is not related to the environment conditions.Report rpt-# "process failure mode and effect analysis", v.7.0 effective date 23jul2019 was evaluated per sop-# "processing consumer complaint", v.13.0 effective date 28feb2019.The potential failure mode of glue blobs at the wrap body side can be classified as too much adhesive and it is included in rpt-#.The actual mitigation controls are: -variable and physical attributes, product geometry inspections performed every 6 minutes for attributes and every 18 for variables (pfmea # i-3) these mitigation controls are appropriate and still effective.Correction: the wrap with glue blobs between the sca laminate (sms side) and the cell pack at the wrap body side under investigation were caused by a defective 0-2 glue module.The issue was resolved under work order number (b)(4).Batch w69234 was release on 05mar2018 and (b)(4) wraps were manufactured.This is the first complaint for batch w69234 related to glue blobs the sca laminate (sms side) and the cell pack at the wrap body side.There are no other complaints related to this defect impacting other thermacare batches at this time.In this case, this product defect does not represent a safety hazard no the customer since the sms material served as a barrier between the customer skin and the glue blobs.Batch w69234 met all product release criteria that include the visual attribute inspection for "major glue blobs/drips" every 10 minutes that detects product with this defect.This investigation recommends no further actions to be taken for batch w69234.Corrective action: no further actions are recommended.There are controls in place to detect the glue blobs observed in the returned samples.Some of them were implemented after the manufacturing of batch w69234.Preventive action: this investigation was generated to document a deviation after its occurrence, no preventive actions were identified.Conclusion: the most probable root cause for this event was classified under is equipment / mechanical failure.It was determined that the glue blobs observed on the returned samples came from a defective nozzle module in gawa 0-2.A work order number (b)(4) was generated to replace the 0-2 glue module after the manufacturing of batch w69234 and the issue was resolved.A defective nozzle module affects the glue spraying and can create glue blobs like the ones observed on the returned sample.This is the most probable cause of this incident.There are no other complaints received for the same batch and defect.Therefore, at this time the defect is considered to be an isolated event.Batch w69234 met all product release criteria that include the visual attribute inspection for "major glue blobs/drips" every 10 minutes that detects product with this defect.There are controls in place to detect the glue blobs observed in the returned samples.Some of them were implemented after the manufacturing of batch w69234.No further action is recommended, batch w69234, remains in release status.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class unidentifiable material in contact with product for investigation received at the albany site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.Return sample evaluation: three wraps- one wrap is inside a completely sealed pouch-no obvious defects.One wrap is inside a partially sealed pouch - wrap is expired.One wrap shows no evidence of brine dosing, glue blobs on one end tab and unidentified specs on the body side of the wrap.It was further reported that there was reasonable suspicion of a device malfunction.The impact was cell leakage and the severity is s3-skin burn- per rpt- # hazard analysis thermacare heat wrap product: 8 and 12 hour.Please evaluate for mdr.The site investigation was in process.Follow-up (30jan2019): new information received from the same contactable consumer includes: expiration date, relevant medical history and concomitant medications (none) and additional event details.Follow-up (11mar2019): new information received from a contactable consumer included: new concomitant medication naproxen, suspect product start date, stop date, and patient was not hospitalization and did not received treatment due to all events.Follow-up attempts are completed.No further information is expected.Follow-up (22mar2019): new information received from the product quality complaint group included investigational results.Follow-up (18may2019): new information received from the product quality complaint group included investigational results.Follow-up (20may2019): new information reported from a contactable consumer includes: concomitant medication naproxen detail (periodically throughout the years), udi dosage and indication for thermacare neck/shoulder, additional description (the wrap was broken and device would not heat- manufacturer defect), action taken updated from permanently withdrawn to dose not changed.Follow-up attempts are completed.No further information is expected.Follow-up (05jun2019): follow-up attempts are completed.No further information is expected.Follow-up (07aug2019): new information received from the product quality complaint group included investigational results.Follow-up (09aug2019): new information received from glaxosmithkline includes impact analysis in the investigation report and case upgraded to malfunction, reportable mdr.Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment: based on the available information, the patient reported it had a defect in the center, top of the pad/the defect was ridged and somewhat sharp, which represents a potential device malfunction (the impact was cell leakage).This malfunction has a theoretical risk to cause skin burn.The other events pain, skin discomfort, and scratch could be caused by this malfunction.The events are medically assessed as associated with the use of the device.The company is conducting further review on this investigation and additional follow-up will be reported when the evaluation is completed.Comment: based on the available information, the patient reported it had a defect in the center, top of the pad/the defect was ridged and somewhat sharp, which represents a potential device malfunction (the impact was cell leakage).This malfunction has a theoretical risk to cause skin burn.The other events pain, skin discomfort, and scratch could be caused by this malfunction.The events are medically assessed as associated with the use of the device.The company is conducting further review on this investigation and additional follow-up will be reported when the evaluation is completed.
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Event Description
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It had a defect in the center, top of the pad which caused it to rub his skin and created a slight bit of pain.[pain], it had a defect in the center, top of the pad which caused it to rub his skin and created a slight bit of pain/something sharp dug into skin [skin discomfort], it was just a quick little scratch, it didn't break the skin [scratch], it had a defect in the center, top of the pad/the defect was ridged and somewhat sharp [device issue].Case narrative: this is a spontaneous report from a contactable consumer reporting for himself.A 76-year-old male patient started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number: w69234, expiration date: jan2021, upc number: 305733015025 (also reported as udi number), from jan2019 at one wrap applied to skin once for slight muscle pain/ slight pain, also reported 1 per day for about a week for neck pain from an unknown date "as pain comes and goes".There was no relevant medical history.Concomitant medication included ongoing naproxen from on (b)(6) 2019, as needed/periodically throughout the years.The patient had been using thermacare products for 10 to 12 years for various reasons, mostly lower back.He just purchased 3 pack neck pain therapy product from a (pharmacy name).It had a defect in the center, top of the pad which caused it to rub his skin and created a slight bit of pain on (b)(6) 2019.The defect was ridged and somewhat sharp.He immediately took it off and also noted it was not warming up.He inspected the other two and found one of them had never been sealed properly.He also inspected the packaging which he tore opened to use the first one-and found the same flaw which was probably why it did not heat.The third one also had a flaw on the "sealing" and was barely sealed up.The patient further reported that he opened the thermacare neck heat wrap, and ripped it open and put it on, and something sharp dug into his skin on (b)(6) 2019.It was just a quick little scratch, it didn't break the skin, so he took it off, it had a serious flaw, like the part had turned rigid and had a tear where it was like cardboard, or plastic, and it also wouldn't heat.He looked at the package again, and it was never sealed.The other 2 in the 3 pack, one had never been sealed, and the other was barely sealed, it had a tiny hole in it.There was something, maybe a chemical that probably made it rigid, he never experienced that.He was ok, but didn't know if there will be any long term effects or anything.When he felt the stick, the scratch, he almost immediately took it off and inspected it, and discontinued use of it.He didn't know if will continue using them, he assumed so, but he will inspect more carefully, as these were sealed in a box.He may or may not continue using them in general.Upon follow up on (b)(6) 2019, the patient stated "have used your thermacare product for years and have never experience an issue.The product in this box were very inferior.The package containing this product was probably never sealed because the device would not heat.In addition, when i applied the device.I was stuck like a pin.By a defect in the device".On (b)(6) 2019, the patient reported "the wrap was broken and device would not heat- manufacturer defect".The patient was not hospitalization and did not received treatment due to all events.The action taken in response to the events for thermacare heatwrap was dose not changed.The outcome of the events was resolved on (b)(6) 2019.A sample of the product was available to be returned.The box was sealed and intact, the wraps had a manufacturer flaw.The patient considered the event "something sharp dug into his skin" was related to the use of the product.According to the product quality complaint group: sub-class: unidentifiable material in contact with product.Root cause analysis/identif: the most probable root cause of this event is equipment / mechanical failure.Equipment (rule-in) the non-woven materials that are stack-up over the cell pack of the thermacare neck shoulder and wrist product are glued by the m-line (assembl name) identified as 0-2 and 1-1.The (assembly name) glue head applicators 0-2 and its modules/nozzles are responsible to spray glue over the sca laminate located at the wrap body side.The sca laminate contains 3 components: the sms material, the skin contact adhesive and the release paper.The sca laminate (sms side) is attached to the carrier web (bottom film) after the glue application from (assembly name) 0-2.(assembly name) 1-1 sprays glue over the carrier web (over top film known as hna) to bond the sms material located at the wrap clothing side.The returned sample shows glue blobs between the sca laminate (sms side) and the cell pack located at the body side.It was determined by (investigator name) (wh) (lead investigator), (specialist name) (gw) (production technical specialist) and asa that these glue blobs came from (assembly name) 0-2.Work order number# was generated to replace the 0-2 glue module after the manufacturing of batch: w69234.A defective nozzle module affects the glue spaying and can create glue blobs like the ones observed on the returned sample.This is the most probable cause of this incident.Asa reviewed the preventive maintenance (pm) for the (assembly name) (# - pm (assembly name) monthly check).There are instructions for nozzle and glue system inspection in a monthly basis.No changes are proposed for this pm.The glue nozzles require cleaning with wax bars to maintain the appropriate glue pattern.Sop-# "equipment cleaning, inspection and lubrication (cil) procedure" includes instructions to clean the m-line critical areas in each production shift and on an ongoing, as needed basis during the shift to ensure line runs effectively and produces good quality product.It includes the (assembly name).The current version of sop-# v11.0, effective date 27feb2019 the critical cils are highlighted in yellow indicating they have priority to be performed first during each manufacturing shift.The (assembly name) are included in the critical category.No changes are proposed for this procedure.There is an in-process quality inspection performed during production of finished product batches.The attribute inspection for major glue blobs/drips is a visual inspection of the wrap and it was conducted for batch: w69234 every 10 minutes of uptime per spec-25353 "neck shoulder wrist (swan) 8hr printed formula card", v.11.0 effective date 04aug2017.The review of the manufacturing attributes and variables inspections associated to batch: w69234 indicates that all required in-process inspections were performed and all inspections criteria were met.There were no wrap attribute or variable defects recorded for batch: w69234.Therefore, this incident is considered an isolated event.This is the first complaint for batch: w69234 related to glue blobs between sca laminate (sms side) and the cell pack at the wrap body side.There are no other complaints related to this defect impacting other thermacare batches at this time.After the manufacturing of batch: w69234, the frequency of the quality inspections (variable and physical attributes, product geometry) was increased from every 10 minutes to every 6 minutes for attributes and from every 20 minutes to every 18 minutes for variables.Therefore, the inspection to detect product defects like glue blobs are more extensive after the manufacturing of batch: w69234.Sop-# "thermacare product attribute measurement" v1.0, effective date: 31jan2018 was created after the manufacturing of batch: w69234.This procedure includes specific instructions of how to perform the different attribute checks.It includes instructions to identify and classify glue blobs according its appearance and size.Also, it describes how to identify gap or issues in the glue pattern.This procedure was created as standardized method to identify and classify defects in the product attribute.Therefore, the manufacturing technicians now are able to identify the glue blobs defects in a standardized way.Based on the information provided above, there are controls in place to detect the glue blobs observed in the returned samples.Some of them (like the increase of quality inspections frequency and the implementation of sop-80350) were implemented after the manufacturing of batch: w69234.No further actions are recommended.Training can be ruled out.The production operators and contingent employees involved in the heat pack maker process have been trained.Method can be ruled out.Sop-# "equipment cleaning, inspection and lubrication (cil) procedure" includes instructions to clean the m-line critical areas in each production shift.It includes the m-line (assembly name) cleaning procedure.Measurement can be ruled out.There is no measurement system related to this event.Material can be ruled out because it is not related to glue blobs issue.Environment was ruled as the root cause because the glue blobs defect is not related to the environment conditions.Report rpt-# "process failure mode and effect analysis", v.7.0 effective date 23jul2019 was evaluated per sop-# "processing consumer complaint", v.13.0 effective date 28feb2019.The potential failure mode of glue blobs at the wrap body side can be classified as too much adhesive and it is included in rpt-#.The actual mitigation controls are: -variable and physical attributes, product geometry inspections performed every 6 minutes for attributes and every 18 for variables (pfmea # i-3) these mitigation controls are appropriate and still effective.Impact analysis: scope / impact analysis: batches: w69234 is within the scope of this investigation.This complaint was classified under complaint sub-class foreign object/contamination-unidentifiable material in contact with product and it is a confirmed device defect.The returned sample shows glue blobs between sms (company name) and bottom film material at the wrap body side.The customer reported that something sharp hurts his skin without breaking it.This part is not confirmed because the glue blobs observed on the returned sample were not hard and sharp to harm the customer skin.The sms material served as a barrier between the customer skin and the glue blobs.The glue blobs diameters were between 3 to 5 mm and they were not in contact with the customer skin.It is categorized as a minor defect since the sample contains more than 3 visible blobs per spec-25353 "neck shoulder wrist (swan) 8hr printed formula card", v.11.0 effective date 04aug2017.In this case, this product defect does not represent a safety hazard no the customer.This batch was manufactured from 26feb2018 to 28feb2018 and was released to market on 05mar2018.The batch is composed of 426,240 wraps packaged into a 3 count configuration.The glue blobs observed between the sms and cell pack (body side) could be caused by issues with m-line glue nozzle 0-2.During batch: w69234 manufacturing there was a visual attribute inspection for "product not meeting design intent" that ensures there are no severe glue/contamination blobs."product not meeting design intent" every 10 minutes that detects product with this defect.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.There were no wrap attribute or variable defects recorded for the batch.This complaint represents three defective wraps of the 426,240 wraps released to market.There have been no other complaints received for this same batch and defect.Therefore, at this time the defect is considered to be an isolated event.Retained samples (3 heatwraps) were reviewed and did not identify any defect.Investigation description: on (b)(6) 2019, a consumer complaint was received in pfizer global complaint electronic database (pcom).It was classified under complaint subclass: foreign object/ contamination unidentifiable material in contact with the product and assigned normal priority.The complaint was acknowledged by (site name) site qa complaint specialist, (name).Consumer complaint: (b)(4) (united states - nsw 8hrs heat wrap, 3 count, batch: w69234, brand code: f00573301502x) will be covered under this full investigation.The consumer complaint represents one nsw wrap, reported with foreign object, out of 426,240 wraps produced for batch: w69234 manufactured on the m line.The production dates for this batch are 26feb2018 through 28feb2018.This is the only batch within the scope of this investigation.An evaluation of the complaint history confirms that this is the first complaint for the sub class foreign object/ contamination unidentifiable material in contact with the product received at the (site name) site requiring an evaluation for this batch.This is the first investigation for batch: w69234; therefore, a trend does not exist for this batch.Immediate action for complaint: (b)(6) (name) notified (name) (qa manager), (name) (site quality operations lead) and (name) (asa) (technical specialist) of the sample wrap with foreign aterial.It was determined to issue a full investigation to determine the root cause of the incident.Correction: the wrap with glue blobs between the sca laminate (sms side) and the cell pack at the wrap body side under investigation were caused by a defective 0-2 glue module.The issue was resolved under work order number: (b)(4).Batch: w69234 was release on 05mar2018 and 426,240 wraps were manufactured.This is the first complaint for batch: w69234 related to glue blobs the sca laminate (sms side) and the cell pack at the wrap body side.There are no other complaints related to this defect impacting other thermacare batches at this time.In this case, this product defect does not represent a safety hazard no the customer since the sms material served as a barrier between the customer skin and the glue blobs.Batch: w69234 met all product release criteria that include the visual attribute inspection for "major glue blobs/drips" every 10 minutes that detects product with this defect.This investigation recommends no further actions to be taken for batch: w69234.Corrective action: no further actions are recommended.There are controls in place to detect the glue blobs observed in the returned samples.Some of them were implemented after the manufacturing of batch: w69234.Preventive action: this investigation was generated to document a deviation after its occurrence, no preventive actions were identified.Conclusion: the most probable root cause for this event was classified under is equipment / mechanical failure.It was determined that the glue blobs observed on the returned samples came from a defective nozzle module in gawa 0-2.A work order number: (b)(4) was generated to replace the 0-2 glue module after the manufacturing of batch: w69234 and the issue was resolved.A defective nozzle module affects the glue spraying and can create glue blobs like the ones observed on the returned sample.This is the most probable cause of this incident.There are no other complaints received for the same batch and defect.Therefore, at this time the defect is considered to be an isolated event.Batch: w69234 met all product release criteria that include the visual attribute inspection for "major glue blobs/drips" every 10 minutes that detects product with this defect.There are controls in place to detect the glue blobs observed in the returned samples.Some of them were implemented after the manufacturing of batch: w69234.No further action is recommended, batch: w69234, remains in release status.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class unidentifiable material in contact with product for investigation received at the albany site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.Return sample evaluation: three wraps- one wrap is inside a completely sealed pouch-no obvious defects.One wrap is inside a partially sealed pouch - wrap is expired.One wrap shows no evidence of brine dosing, glue blobs on one end tab and unidentified specs on the body side of the wrap.Three pouches have an incomplete seal on one end seal.Carton is open.It was further reported that there was reasonable suspicion of a device malfunction.The impact was cell leakage and the severity is s3-skin burn- per rpt- # hazard analysis thermacare heat wrap product: 8 and 12 hour.Follow-up (30jan2019): new information received from the same contactable consumer includes: expiration date, relevant medical history and concomitant medications (none) and additional event details.Follow-up (11mar2019): new information received from a contactable consumer included: new concomitant medication naproxen, suspect product start date, stop date, and patient was not hospitalization and did not received treatment due to all events.Follow-up attempts are completed.No further information is expected.Follow-up (22mar2019): new information received from the product quality complaint group included investigational results.Follow-up (18may2019): new information received from the product quality complaint group included investigational results.Follow-up (20may2019): new information reported from a contactable consumer includes: concomitant medication naproxen detail (periodically throughout the years), udi dosage and indication for thermacare neck/shoulder, additional description (the wrap was broken and device would not heat- manufacturer defect), action taken updated from permanently withdrawn to dose not changed.Follow-up attempts are completed.No further information is expected.Follow-up (05jun2019): follow-up attempts are completed.No further information is expected.Follow-up (07aug2019): new information received from the product quality complaint group included investigational results.Follow-up (09aug2019): new information received from glaxosmithkline includes impact analysis in the investigation report and case upgraded to malfunction, reportable mdr.Follow-up attempts are completed.No further information is expected.Follow-up (19aug2019): new information received from glaxosmithkline includes impact analysis in the investigation report.Company clinical evaluation comment: based on the available information, the patient reported it had a defect in the center, top of the pad/the defect was ridged and somewhat sharp, which represents a potential device malfunction (the impact was cell leakage).This malfunction has a theoretical risk to cause skin burn.The other events pain, skin discomfort, and scratch could be caused by this malfunction.The events are medically assessed as associated with the use of the device.Company conducted an investigation, the most probable root cause for this event was classified and no further action is recommended., comment: based on the available information, the patient reported it had a defect in the center, top of the pad/the defect was ridged and somewhat sharp, which represents a potential device malfunction (the impact was cell leakage).This malfunction has a theoretical risk to cause skin burn.The other events pain, skin discomfort, and scratch could be caused by this malfunction.The events are medically assessed as associated with the use of the device.Company conducted an investigation, the most probable root cause for this event was classified and no further action is recommended.
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Manufacturer Narrative
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It was further reported that there was reasonable suspicion of a device malfunction.The impact was cell leakage and the severity is s3-skin burn- per rpt- # hazard analysis thermacare heat wrap product: 8 and 12 hour.Sub-class: unidentifiable material in contact with product.Root cause analysis/identif: the most probable root cause of this event is equipment / mechanical failure.Equipment (rule-in) the non-woven materials that are stack-up over the cell pack of the thermacare neck shoulder and wrist product are glued by the m-line (assembl name) identified as 0-2 and 1-1.The (assembly name) glue head applicators 0-2 and its modules/nozzles are responsible to spray glue over the sca laminate located at the wrap body side.The sca laminate contains 3 components: the sms material, the skin contact adhesive and the release paper.The sca laminate (sms side) is attached to the carrier web (bottom film) after the glue application from (assembly name) 0-2.(assembly name) 1-1 sprays glue over the carrier web (over top film known as hna) to bond the sms material located at the wrap clothing side.The returned sample shows glue blobs between the sca laminate (sms side) and the cell pack located at the body side.It was determined by (investigator name) (wh) (lead investigator), (specialist name) (gw) (production technical specialist) and asa that these glue blobs came from (assembly name) 0-2.Work order number# was generated to replace the 0-2 glue module after the manufacturing of batch: w69234.A defective nozzle module affects the glue spaying and can create glue blobs like the ones observed on the returned sample.This is the most probable cause of this incident.Asa reviewed the preventive maintenance (pm) for the (assembly name) (# - pm (assembly name) monthly check).There are instructions for nozzle and glue system inspection in a monthly basis.No changes are proposed for this pm.The glue nozzles require cleaning with wax bars to maintain the appropriate glue.
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Event Description
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It had a defect in the center, top of the pad which caused it to rub his skin and created a slight bit of pain.[pain], it had a defect in the center, top of the pad which caused it to rub his skin and created a slight bit of pain/something sharp dug into skin [skin discomfort], it was just a quick little scratch, it didn't break the skin [scratch], it had a defect in the center, top of the pad/the defect was ridged and somewhat sharp [device issue].Case narrative: this is a spontaneous report from a contactable consumer reporting for himself.A 76-year-old male patient started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number: w69234, expiration date: jan2021, upc number: 305733015025 (also reported as udi number), from on (b)(6) 2019 at one wrap applied to skin once for slight muscle pain/ slight pain, also reported 1 per day for about a week for neck pain from an unknown date "as pain comes and goes".There was no relevant medical history.Concomitant medication included ongoing naproxen from on (b)(6) 2019, as needed/periodically throughout the years.The patient had been using thermacare products for 10 to 12 years for various reasons, mostly lower back.He just purchased 3 pack neck pain therapy product from a (pharmacy name).It had a defect in the center, top of the pad which caused it to rub his skin and created a slight bit of pain on (b)(6) 2019.The defect was ridged and somewhat sharp.He immediately took it off and also noted it was not warming up.He inspected the other two and found one of them had never been sealed properly.He also inspected the packaging which he tore opened to use the first one-and found the same flaw which was probably why it did not heat.The third one also had a flaw on the "sealing" and was barely sealed up.The patient further reported that he opened the thermacare neck heat wrap, and ripped it open and put it on, and something sharp dug into his skin on (b)(6) 2019.It was just a quick little scratch, it didn't break the skin, so he took it off, it had a serious flaw, like the part had turned rigid and had a tear where it was like cardboard, or plastic, and it also wouldn't heat.He looked at the package again, and it was never sealed.The other 2 in the 3 pack, one had never been sealed, and the other was barely sealed, it had a tiny hole in it.There was something, maybe a chemical that probably made it rigid, he never experienced that.He was ok, but didn't know if there will be any long term effects or anything.When he felt the stick, the scratch, he almost immediately took it off and inspected it, and discontinued use of it.He didn't know if will continue using them, he assumed so, but he will inspect more carefully, as these were sealed in a box.He may or may not continue using them in general.Upon follow up on (b)(6) 2019, the patient stated "have used your thermacare product for years and have never experience an issue.The product in this box were very inferior.The package containing this product was probably never sealed because the device would not heat.In addition, when i applied the device.I was stuck like a pin.By a defect in the device".On (b)(6) 2019, the patient reported "the wrap was broken and device would not heat- manufacturer defect".The patient was not hospitalization and did not received treatment due to all events.The action taken in response to the events for thermacare heatwrap was dose not changed.The outcome of the events was resolved on (b)(6) 2019.A sample of the product was available to be returned.The box was sealed and intact, the wraps had a manufacturer flaw.The patient considered the event "something sharp dug into his skin" was related to the use of the product.According to the product quality complaint group: root cause of open pouches is equipment; specifically, ultrasonic seal technology is not as forgiving in relation to the foil material as heat seal technology (external machine factors such as process variability and film material variability (wavy, wrinkles, thickness, surly conditions, etc.) affect the ability to keep the required film/product alignment and even pressure of the anvils across the sealing areas thus, compromising sealing integrity).In general, the leak defect rate has remained unchanged despite several reliability and engineering initiatives to improve the sealing performance.Heat seal technology offers a more "forgiving" process to accommodate some of these variations and still achieve a hermetic seal, critical to the functionality and longevity of the thermacare product.Capa: the (site name) consumer site will purchase and install three (3) new heat seal flow wrapper machines for b and m production lines.The existing bosch flow wrapper equipment used today employs ultrasonic sealing technology for both, the long and cross seals of the thermacare pouches.This technology has proven to be unreliable, difficult to maintain and not flexible enough to accommodate for material variances.The highest consumer complaint for the site is related to pouch sealing defects and the product never worked due to an open pouch.These complaints are directly related to failures during the sealing process.The new machines will utilize heat seal in the cross direction of the film/pouch to achieve a more consistent hermetic seal through the manufacturing runs with the added benefits of easier set up and operation.Complaints received at the site in the global complaint database related to open pouch in the subclasses of (but not limited to) never worked, squeeze tube, did not last long enough and too cool will not be investigated in qts.These complaints will be evaluated in the global complaint database to ensure they are due to "open pouch" and the pouch sealing defect.No additional investigation will be required for these complaints based on the following:released batches meet criteria for pouch leaks at time of release-the severity of pouch leaks is s1 -no harm to customer-complaints related to pouch seal have been thoroughly investigated and root cause is well understood-leak rate for the current technology is about 2000 ppm-capa is in-place to replace the ultrasonic sealers with heat seal technology.This document will be attached to the complaint record in the global database and closed with no further action taken.The root cause for never worked, too cool, did not last long enough and squeeze tube complaint sub classless is due to a pouch (primary packaging) that did not seal completely (open pouch).An open pouch will expose the wrap to air before the consumer gets it, causing it to be spent and not heating up.An open pouch is caused by equipment; specifically, ultrasonic technology.The corrective action is to purchase and install three (3) new heat seal flow wrapper machines in both production lines.The severity of pouch leaks is s1 no harm to customer.According to the product quality complaint group: sub-class: unidentifiable material in contact with product.Root cause analysis/identif: the most probable root cause of this event is equipment / mechanical failure.Equipment (rule-in) the non-woven materials that are stack-up over the cell pack of the thermacare neck shoulder and wrist product are glued by the m-line (assembl name) identified as 0-2 and 1-1.The (assembly name) glue head applicators 0-2 and its modules/nozzles are responsible to spray glue over the sca laminate located at the wrap body side.The sca laminate contains 3 components: the sms material, the skin contact adhesive and the release paper.The sca laminate (sms side) is attached to the carrier web (bottom film) after the glue application from (assembly name) 0-2.(assembly name) 1-1 sprays glue over the carrier web (over top film known as hna) to bond the sms material located at the wrap clothing side.The returned sample shows glue blobs between the sca laminate (sms side) and the cell pack located at the body side.It was determined by (investigator name) (wh) (lead investigator), (specialist name) (gw) (production technical specialist) and asa that these glue blobs came from (assembly name) 0-2.Work order number# was generated to replace the 0-2 glue module after the manufacturing of batch: w69234.A defective nozzle module affects the glue spaying and can create glue blobs like the ones observed on the returned sample.This is the most probable cause of this incident.Asa reviewed the preventive maintenance (pm) for the (assembly name) (# - pm (assembly name) monthly check).There are instructions for nozzle and glue system inspection in a monthly basis.No changes are proposed for this pm.The glue nozzles require cleaning with wax bars to maintain the appropriate glue pattern.There is an in-process quality inspection performed during production of finished product batches.The attribute inspection for major glue blobs/drips is a visual inspection of the wrap and it was conducted for batch: w69234 every 10 minutes of uptime per spec-25353 "neck shoulder wrist (swan) 8hr printed formula card", v.11.0 effective date 04aug2017.The review of the manufacturing attributes and variables inspections associated to batch: w69234 indicates that all required in-process inspections were performed and all inspections criteria were met.There were no wrap attribute or variable defects recorded for batch: w69234.Therefore, this incident is considered an isolated event.This is the first complaint for batch: w69234 related to glue blobs between sca laminate (sms side) and the cell pack at the wrap body side.There are no other complaints related to this defect impacting other thermacare batches at this time.After the manufacturing of batch: w69234, the frequency of the quality inspections (variable and physical attributes, product geometry) was increased from every 10 minutes to every 6 minutes for attributes and from every 20 minutes to every 18 minutes for variables.Therefore, the inspection to detect product defects like glue blobs are more extensive after the manufacturing of batch: w69234.Based on the information provided above, there are controls in place to detect the glue blobs observed in the returned samples.Some of them (like the increase of quality inspections frequency and the implementation of sop-80350) were implemented after the manufacturing of batch: w69234.No further actions are recommended.Training can be ruled out.The production operators and contingent employees involved in the heat pack maker process have been trained.Method can be ruled out.Sop-# "equipment cleaning, inspection and lubrication (cil) procedure" includes instructions to clean the m-line critical areas in each production shift.It includes the m-line (assembly name) cleaning procedure.Measurement can be ruled out.There is no measurement system related to this event.Material can be ruled out because it is not related to glue blobs issue.Environment was ruled as the root cause because the glue blobs defect is not related to the environment conditions.Report rpt-# "process failure mode and effect analysis", v.7.0 effective date 23jul2019 was evaluated per sop-# "processing consumer complaint", v.13.0 effective date 28feb2019.The potential failure mode of glue blobs at the wrap body side can be classified as too much adhesive and it is included in rpt-#.The actual mitigation controls are: -variable and physical attributes, product geometry inspections performed every 6 minutes for attributes and every 18 for variables (pfmea # i-3) these mitigation controls are appropriate and still effective.Impact analysis: scope / impact analysis: batches: w69234 is within the scope of this investigation.This complaint was classified under complaint sub-class foreign object/contamination-unidentifiable material in contact with product and it is a confirmed device defect.The returned sample shows glue blobs between sms (company name) and bottom film material at the wrap body side.The customer reported that something sharp hurts his skin without breaking it.This part is not confirmed because the glue blobs observed on the returned sample were not hard and sharp to harm the customer skin.The sms material served as a barrier between the customer skin and the glue blobs.The glue blobs diameters were between 3 to 5 mm and they were not in contact with the customer skin.It is categorized as a minor defect since the sample contains more than 3 visible blobs per spec-25353 "neck shoulder wrist (swan) 8hr printed formula card", v.11.0 effective date 04aug2017.In this case, this product defect does not represent a safety hazard no the customer.This batch was manufactured from 26feb2018 to 28feb2018 and was released to market on 05mar2018.The batch is composed of 426,240 wraps packaged into a 3 count configuration.The glue blobs observed between the sms and cell pack (body side) could be caused by issues with m-line glue nozzle 0-2.During batch: w69234 manufacturing there was a visual attribute inspection for "product not meeting design intent" that ensures there are no severe glue/contamination blobs."product not meeting design intent" every 10 minutes that detects product with this defect.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.There were no wrap attribute or variable defects recorded for the batch.This complaint represents three defective wraps of the 426,240 wraps released to market.There have been no other complaints received for this same batch and defect.Therefore, at this time the defect is considered to be an isolated event.Retained samples (3 heatwraps) were reviewed and did not identify any defect.Correction: the wrap with glue blobs between the sca laminate (sms side) and the cell pack at the wrap body side under investigation were caused by a defective 0-2 glue module.The issue was resolved under work order number: (b)(4).Batch: w69234 was release on 05mar2018 and 426,240 wraps were manufactured.This is the first complaint for batch: w69234 related to glue blobs the sca laminate (sms side) and the cell pack at the wrap body side.There are no other complaints related to this defect impacting other thermacare batches at this time.In this case, this product defect does not represent a safety hazard no the customer since the sms material served as a barrier between the customer skin and the glue blobs.Batch: w69234 met all product release criteria that include the visual attribute inspection for "major glue blobs/drips" every 10 minutes that detects product with this defect.This investigation recommends no further actions to be taken for batch: w69234.Corrective action: no further actions are recommended.There are controls in place to detect the glue blobs observed in the returned samples.Some of them were implemented after the manufacturing of batch: w69234.Preventive action: this investigation was generated to document a deviation after its occurrence, no preventive actions were identified.Conclusion: the most probable root cause for this event was classified under is equipment / mechanical failure.It was determined that the glue blobs observed on the returned samples came from a defective nozzle module in gawa 0-2.A work order number: (b)(4) was generated to replace the 0-2 glue module after the manufacturing of batch: w69234 and the issue was resolved.A defective nozzle module affects the glue spraying and can create glue blobs like the ones observed on the returned sample.This is the most probable cause of this incident.There are no other complaints received for the same batch and defect.Therefore, at this time the defect is considered to be an isolated event.Batch: w69234 met all product release criteria that include the visual attribute inspection for "major glue blobs/drips" every 10 minutes that detects product with this defect.There are controls in place to detect the glue blobs observed in the returned samples.Some of them were implemented after the manufacturing of batch: w69234.No further action is recommended, batch: w69234, remains in release status.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class unidentifiable material in contact with product for investigation received at the albany site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.Return sample evaluation: three wraps- one wrap is inside a completely sealed pouch-no obvious defects.One wrap is inside a partially sealed pouch - wrap is expired.One wrap shows no evidence of brine dosing, glue blobs on one end tab and unidentified specs on the body side of the wrap.Three pouches have an incomplete seal on one end seal.Carton is open.It was further reported that there was reasonable suspicion of a device malfunction.The impact was cell leakage and the severity is s3-skin burn- per rpt- # hazard analysis thermacare heat wrap product: 8 and 12 hour.Follow-up (30jan2019): new information received from the same contactable consumer includes: expiration date, relevant medical history and concomitant medications (none) and additional event details.Follow-up (11mar2019): new information received from a contactable consumer included: new concomitant medication naproxen, suspect product start date, stop date, and patient was not hospitalization and did not received treatment due to all events.Follow-up attempts are completed.No further information is expected.Follow-up (22mar2019): new information received from the product quality complaint group included investigational results.Follow-up (18may2019): new information received from the product quality complaint group included investigational results.Follow-up (20may2019): new information reported from a contactable consumer includes: concomitant medication naproxen detail (periodically throughout the years), udi dosage and indication for thermacare neck/shoulder, additional description (the wrap was broken and device would not heat- manufacturer defect), action taken updated from permanently withdrawn to dose not changed.Follow-up attempts are completed.No further information is expected.Follow-up (05jun2019): follow-up attempts are completed.No further information is expected.Follow-up (07aug2019): new information received from the product quality complaint group included investigational results.Follow-up (09aug2019): new information received from glaxosmithkline includes impact analysis in the investigation report and case upgraded to malfunction, reportable mdr.Follow-up attempts are completed.No further information is expected.Follow-up (19aug2019): new information received from glaxosmithkline includes impact analysis in the investigation report.Amendment: this follow-up report is being submitted to amend previously reported information: investigation results for evaluation of complaints related to open pouches was added.Company clinical evaluation comment: based on the available information, the patient reported it had a defect in the center, top of the pad/the defect was ridged and somewhat sharp, which represents a potential device malfunction (the impact was cell leakage).This malfunction has a theoretical risk to cause skin burn.The other events pain, skin discomfort, and scratch could be caused by this malfunction.The events are medically assessed as associated with the use of the device.Company conducted an investigation, the most probable root cause for this event was classified and no further action is recommended., comment: based on the available information, the patient reported it had a defect in the center, top of the pad/the defect was ridged and somewhat sharp, which represents a potential device malfunction (the impact was cell leakage).This malfunction has a theoretical risk to cause skin burn.The other events pain, skin discomfort, and scratch could be caused by this malfunction.The events are medically assessed as associated with the use of the device.Company conducted an investigation, the most probable root cause for this event was classified and no further action is recommended.
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Manufacturer Narrative
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Sub-class: unidentifiable material in contact with product.Root cause analysis/identif: the most probable root cause of this event is equipment / mechanical failure.Equipment (rule-in) the non-woven materials that are stack-up over the cell pack of the thermacare neck shoulder and wrist product are glued by the m-line (assembl name) identified as 0-2 and 1-1.The (assembly name) glue head applicators 0-2 and its modules/nozzles are responsible to spray glue over the sca laminate located at the wrap body side.The sca laminate contains 3 components: the sms material, the skin contact adhesive and the release paper.The sca laminate (sms side) is attached to the carrier web (bottom film) after the glue application from (assembly name) 0-2.(assembly name) 1-1 sprays glue over the carrier web (over top film known as hna) to bond the sms material located at the wrap clothing side.The returned sample shows glue blobs between the sca laminate (sms side) and the cell pack located at the body side.It was determined by (investigator name) (wh) (lead investigator), (specialist name) (gw) (production technical specialist) and asa that these glue blobs came from (assembly name) 0-2.Work order number# was generated to replace the 0-2 glue module after the manufacturing of batch: w69234.A defective nozzle module affects the glue spaying and can create glue blobs like the ones observed on the returned sample.This is the most probable cause of this incident.Asa reviewed the preventive maintenance (pm) for the (assembly name) (# - pm (assembly name) monthly check).There are instructions for nozzle and glue system inspection in a monthly basis.No changes are proposed for this pm.The glue nozzles require cleaning with wax bars to maintain the appropriate glue pattern.There is an in-process quality inspection performed during production of finished product batches.The attribute inspection for major glue blobs/drips is a visual inspection of the wrap and it was conducted fo.
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Search Alerts/Recalls
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