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| Lot Number X17277 |
| Device Problems
Fluid/Blood Leak (1250); Defective Device (2588); Contamination /Decontamination Problem (2895); Material Deformation (2976)
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| Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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Sample evaluation: photos were attached in pcom.Photos show two lbh wraps with cell packs cut and leaking chemistry to outside of wrap.One photo shows the carton with coding: (l) x17277 may2017 exp apr2021 01:33.Site investigation #: (b)(4); severity rank: s3; device malfunction confirmed per (b)(4) bridging pfizer hal severity numbers applied in the thermacare heatwrap rmp, effective (b)(6) 2018, version 1.0 # 1.1.1.1 potential hazard - skin burn, d2.2.2.1-die cut cell, severity rank s3.
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Event Description
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Event verbatim [preferred term] both wraps were not cut properly and the black stuff was falling out of the pouches [device leakage].Case narrative:the initial case was missing the following minimum criteria: no indication the consumer experienced an adverse event under thermacare, only a product complaint.Upon receipt of follow-up information on (b)(6) 2018, this case now contains all required information to be considered valid.This is a spontaneous report from a contactable consumer or other non hcp.A patient of unspecified age and gender started to use thermacare heatwrap (thermacare lower back & hip) (device lot number x17277, expiration date apr2021) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.On an unspecified date, the patient reported they purchased a defective box of thermacare heatwraps.They stated both wraps were not cut properly and the black stuff was falling out of the pouches on the bottom row.Action taken with the suspect product was unknown.Clinical outcome of the event was unknown.Additional information received from product quality complaint (pqc) group included investigation results.Sample evaluation: photos were attached in pcom.Photos show two lbh wraps with cell packs cut and leaking chemistry to outside of wrap.One photo shows the carton with coding: (l) x17277 (b)(6) 2017 exp apr2021 01:33.Site investigation #: (b)(4); severity rank: s3; device malfunction confirmed per (b)(4) bridging pfizer hal severity numbers applied in the thermacare heatwrap rmp, effective (b)(6) 2018, version 1.0 # 1.1.1.1 potential hazard - skin burn, d2.2.2.1-die cut cell, severity rank s3.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment : the device malfunction from the returned sample has been confirmed.This malfunction has been identified prior to use of the device and the consumer did not use the device.No adverse event was associated with the use of the device.This single event malfunction has a theoretical risk to cause skin burn.The company is conducting further review on this investigation and additional follow-up will be reported when the evaluation is completed., comment: the device malfunction from the returned sample has been confirmed.This malfunction has been identified prior to use of the device and the consumer did not use the device.No adverse event was associated with the use of the device.This single event malfunction has a theoretical risk to cause skin burn.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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Manufacturer Narrative
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Sample evaluation: photos were attached in pcom.Photos show two lbh wraps with cell packs cut and leaking chemistry to outside of wrap.One photo shows the carton with coding: (l) x17277 may2017 exp apr2021 01:33.Site investigation#: (b)(4); severity rank: s3; device malfunction confirmed per rpt- 74091 bridging pfizer hal severity numbers applied in the thermacare heatwrap rmp, effective 28sep2018, version 1.0 # 1.1.1.1 potential hazard - skin burn, d2.2.2.1-die cut cell, severity rank s3.Initial complaint assessment: batch: x17277 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of retain samples included five cartons, 10 pouches and the 10 wraps inside.Inspection shows no obvious defects to cartons, pouches or wraps.Form-46455 retain sample inspection form documented the retain evaluation performed on 27nov2018.An evaluation of the complaint history confirms that this is the first complaint for the sub class cells damaged/leaking for this batch.On the basis of this evaluation, a trend does not exist for this batch.The pcom search returned a total of 40 complaints for lower back and hip (lbh) products during this time period for the class/subclass.Of the 40 complaints; 12 complaints have batch number recorded as "unknown".The 28 remaining complaints were evaluated.Five of the 28 records were identified as having a manufacturing related root cause of the wrap having cells/damaged/ leaking defects.Scope / impact analysis: batch: x17277 is within the scope of this investigation.No additional batches have been impacted by this incident.Assessment of the thermacare heatwraps hazards associated to the product defect under investigation was performed per rpt-74091 ¿bridging pfizer hal severity ranking to severity numbers applied in the thermacare heatwrap rmp¿, version 1.0, effective date: 28sep2018.This complaint was for cut cells on the lbh heat wrap and it is a confirm.
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Event Description
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Both wraps were not cut properly and the black stuff was falling out of the pouches [device leakage].Case narrative: the initial case was missing the following minimum criteria: no indication the consumer experienced an adverse event under thermacare, only a product complaint.Upon receipt of follow-up information on 25nov2018, this case now contains all required information to be considered valid.This is a spontaneous report from a contactable consumer.A patient of unspecified age and gender started to use thermacare heatwrap (thermacare lower back & hip) (device lot number: x17277, expiration date: apr2021) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.On an unspecified date, the patient reported they purchased a defective box of thermacare heatwraps.They stated both wraps were not cut properly and the black stuff was falling out of the pouches on the bottom row.Action taken with the suspect product was unknown.Clinical outcome of the event was unknown.Additional information received from product quality complaint (pqc) group included investigation results.Sample evaluation: photos were attached in pcom.Photos show two lbh wraps with cell packs cut and leaking chemistry to outside of wrap.One photo shows the carton with coding: (l) x17277 may2017 exp: apr2021 01:33.Site investigation#: (b)(4); severity rank: s3; device malfunction confirmed per rpt- 74091 bridging pfizer hal severity numbers applied in the thermacare heatwrap rmp, effective 28sep2018, version 1.0 # 1.1.1.1 potential hazard - skin burn, d2.2.2.1-die cut cell, severity rank s3.Initial complaint assessment: batch: x17277 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of retain samples included five cartons, 10 pouches and the 10 wraps inside.Inspection shows no obvious defects to cartons, pouches or wraps.Form-46455 retain sample inspection form documented the retain evaluation performed on 27nov2018.An evaluation of the complaint history confirms that this is the first complaint for the sub class cells damaged/leaking for this batch.On the basis of this evaluation, a trend does not exist for this batch.The pcom search returned a total of 40 complaints for lower back and hip (lbh) products during this time period for the class/subclass.Of the 40 complaints; 12 complaints have batch number recorded as "unknown".The 28 remaining complaints were evaluated.Five of the 28 records were identified as having a manufacturing related root cause of the wrap having cells/damaged/ leaking defects.Scope / impact analysis: batch: x17277 is within the scope of this investigation.No additional batches have been impacted by this incident.Assessment of the thermacare heatwraps hazards associated to the product defect under investigation was performed per rpt-74091 "bridging pfizer hal severity ranking to severity numbers applied in the thermacare heatwrap rmp", version 1.0, effective date: 28sep2018.This complaint was for cut cells on the lbh heat wrap and it is a confirmed device malfunction.Severity level: s3 (serious).Potential hazard id: 1.1.1.1.Potential hazard: individual cell too hot.Potential cause id: it is not included in rpt-74091.A commitment will be generated to update rpt-74091.Potential cause-failure mechanism description: it is not included in rpt-74091.A commitment will be generated to update rpt-74091.This batch was manufactured from 14may2018 to 17may2018 and was released to market on 24may2018.The batch is composed of (b)(4) wraps packaged into a 2 count configuration.The cut cells were caused by a potential die registration optics misalignment scenario created by an unassisted carrier web (uws0) splice that made physical contact with the optics.During batch: x17277 manufacturing there was a visual attribute inspection for "heat pack integrity" 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 two defective wraps of the 301,464 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.The chemistry leakage is visual upon opening the wrap.There are specific product use instructions on the carton, pouch film and insert stating, "do not use if the heat cell contents leak and/or wrap is damaged or torn".There is no trend for this batch related to cells damaged/leaking per site procedures.Retained samples (10 heatwraps) were reviewed and did not identify any defect.Correction: the wraps with cut cells allowing to the premix chemistry coming out of the cells (leaking) were caused by a potential misaligned of the die registration optics.Batch: x17277 was release on 24may2018 and 301,464 wraps were manufactured.This is the first complaint for batch: x17277 related to cut cell wraps allowing to the premix chemistry coming out of the cells.At this time the defect is considered to be an isolated event.Batch: x17277 met all product release criteria that include the visual attribute inspection for "heat pack integrity" every 10 minutes that detects product with this defect.The chemistry leakage is visual upon opening the wrap.There are specific product use instructions on the carton, pouch film and insert stating, "do not use if the heat cell contents leak and/or wrap is damaged or torn"; therefore, this investigation recommends no further actions to be taken for batch: x17277.Conclusion: the most probable root cause of this event is method/document doesn't exist.This defect could occur after the splice broke out (came apart) of the web on 17may2018.The re-taping of the web that created a gathered up (bunched up) web misaligned the die registration optics when it passed between the optics.This splice should be assisted (move away) by the manufacturing technician to prevent physical contact with the registration optics.There is no procedure in place that provides instructions to manage this kind of splice.This is the most probable cause of this incident.No market action was determined for batch: x17277 because this is the first complaint of this defect for this batch.At this time the defect is considered to be an isolated event for batch: x17277.No additional batches have been impacted by this incident.The chemistry leakage from cut cells is visible upon opening the wrap and there are specific product use instructions on the carton, pouch film and insert stating, "do not use if the heat cell contents leak and/or wrap is damaged or torn".Qa summary and impact: the most probable root cause is related to the wrap was cut by the die cutter after a splice caused a misalignment of the die registration optics.At this time the defect is considered to be an isolated event.Batch: x17277 met all product release criteria that include the visual attribute inspection for "heat pack integrity" every 10 minutes that detects product with this defect.The chemistry leakage is visual upon opening the wrap.There are specific product use instructions on the carton, pouch film and insert stating, "do not use if the heat cell contents leak and/or wrap is damaged or torn"; therefore, this investigation recommends no further actions to be taken for batch: x17277.Follow-up (03may2019): new information received from a contactable consumer via product quality complaints group included: investigation results.Company clinical evaluation comment : the device malfunction from the returned sample has been confirmed.This malfunction has been identified prior to use of the device and the consumer did not use the device.No adverse event was associated with the use of the device.This single event malfunction has a theoretical risk to cause skin burn.The review of the lot/batch records does not suggest a quality issue related to the manufacture of this lot; the defect considered was an isolated event for batch: x17277.No further investigations or actions are suggested at this time.Comment: the device malfunction from the returned sample has been confirmed.This malfunction has been identified prior to use of the device and the consumer did not use the device.No adverse event was associated with the use of the device.This single event malfunction has a theoretical risk to cause skin burn.The review of the lot/batch records does not suggest a quality issue related to the manufacture of this lot; the defect considered was an isolated event for batch: x17277.No further investigations or actions are suggested at this time.
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Manufacturer Narrative
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Sample evaluation: photos were attached in pcom.Photos show two lbh wraps with cell packs cut and leaking chemistry to outside of wrap.One photo shows the carton with coding: (l) x17277 may2017 exp apr2021 01:33.Site investigation #: pr 2505968; severity rank: s3; device malfunction confirmed per rpt- 74091 bridging pfizer hal severity numbers applied in the thermacare heatwrap rmp, effective 28sep2018, version 1.0 # 1.1.1.1 potential hazard - skin burn, d2.2.2.1-die cut cell, severity rank s3.Initial complaint assessment: batch x17277 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of retain samples included five cartons, 10 pouches and the 10 wraps inside.Inspection shows no obvious defects to cartons, pouches or wraps.Form-46455 retain sample inspection form documented the retain evaluation performed on 27nov2018.An evaluation of the complaint history confirms that this is the first complaint for the sub class cells damaged/leaking for this batch.On the basis of this evaluation, a trend does not exist for this batch.The pcom search returned a total of 40 complaints for lower back and hip (lbh) products during this time period for the class/subclass.Of the (b)(4) complaints; (b)(4) complaints have batch number recorded as "unknown".The (b)(4) remaining complaints were evaluated.Five of the (b)(4) records were identified as having a manufacturing related root cause of the wrap having cells/damaged/ leaking defects.Scope / impact analysis: batch x17277 is within the scope of this investigation.No additional batches have been impacted by this incident.Assessment of the thermacare heatwraps hazards associated to the product defect under investigation was performed per rpt-74091 ¿bridging pfizer hal severity ranking to severity numbers applied in the thermacare heatwrap rmp¿, version 1.0, effective date: 28sep2018.This complaint was for cut cells on the lbh heat wrap and it is a confirm.
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Event Description
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Event verbatim [preferred term] both wraps were not cut properly and the black stuff was falling out of the pouches [device leakage] ,.Case narrative:the initial case was missing the following minimum criteria: no indication the consumer experienced an adverse event under thermacare, only a product complaint.Upon receipt of follow-up information on (b)(6)2018, this case now contains all required information to be considered valid.This is a spontaneous report from a contactable consumer.A patient of unspecified age and gender started to use thermacare heatwrap (thermacare lower back & hip) (device lot number x17277, expiration date apr2021) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.On an unspecified date, the patient reported they purchased a defective box of thermacare heatwraps.They stated both wraps were not cut properly and the black stuff was falling out of the pouches on the bottom row.Both were un-useable.The patient had pictures of both wraps.Action taken with the suspect product was unknown.Clinical outcome of the event was unknown.Additional information received from product quality complaint (pqc) group included investigation results.Sample evaluation: photos were attached in pcom.Photos show two lbh wraps with cell packs cut and leaking chemistry to outside of wrap.One photo shows the carton with coding: (l) x17277 may2017 exp apr2021 01:33.Site investigation #: pr 2505968; severity rank: s3; device malfunction confirmed per rpt- 74091 bridging pfizer hal severity numbers applied in the thermacare heatwrap rmp, effective 28sep2018, version 1.0 # 1.1.1.1 potential hazard - skin burn, d2.2.2.1-die cut cell, severity rank s3.Initial complaint assessment: batch x17277 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of retain samples included five cartons, 10 pouches and the 10 wraps inside.Inspection shows no obvious defects to cartons, pouches or wraps.Form-46455 retain sample inspection form documented the retain evaluation performed on 27nov2018.An evaluation of the complaint history confirms that this is the first complaint for the sub class cells damaged/leaking for this batch.On the basis of this evaluation, a trend does not exist for this batch.The pcom search returned a total of 40 complaints for lower back and hip (lbh) products during this time period for the class/subclass.Of the (b)(4) complaints; (b)(4) complaints have batch number recorded as "unknown".The 28 remaining complaints were evaluated.Five of the (b)(4) records were identified as having a manufacturing related root cause of the wrap having cells/damaged/ leaking defects.Scope / impact analysis: batch x17277 is within the scope of this investigation.No additional batches have been impacted by this incident.Assessment of the thermacare heatwraps hazards associated to the product defect under investigation was performed per rpt-74091 "bridging pfizer hal severity ranking to severity numbers applied in the thermacare heatwrap rmp", version 1.0, effective date: 28sep2018.This complaint was for cut cells on the lbh heat wrap and it is a confirmed device malfunction.Severity level: s3 (serious).Potential hazard id: 1.1.1.1.Potential hazard: individual cell too hot.Potential cause id: it is not included in rpt-74091.A commitment will be generated to update rpt-74091.Potential cause-failure mechanism description: it is not included in rpt-74091.A commitment will be generated to update rpt-74091.This batch was manufactured from 14may2018 to 17may2018 and was released to market on 24may2018.The batch is composed of (b)(4) wraps packaged into a 2 count configuration.The cut cells were caused by a potential die registration optics misalignment scenario created by an unassisted carrier web (uws0) splice that made physical contact with the optics.During batch x17277 manufacturing there was a visual attribute inspection for "heat pack integrity" 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 two defective wraps of the (b)(4) 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.The chemistry leakage is visual upon opening the wrap.There are specific product use instructions on the carton, pouch film and insert stating, "do not use if the heat cell contents leak and/or wrap is damaged or torn".There is no trend for this batch related to cells damaged/leaking per site procedures.Retained samples (10 heatwraps) were reviewed and did not identify any defect.Correction: the wraps with cut cells allowing to the premix chemistry coming out of the cells (leaking) were caused by a potential misaligned of the die registration optics.Batch x17277 was release on 24may2018 and (b)(4) wraps were manufactured.This is the first complaint for batch x17277 related to cut cell wraps allowing to the premix chemistry coming out of the cells.At this time the defect is considered to be an isolated event.Batch x17277 met all product release criteria that include the visual attribute inspection for "heat pack integrity" every 10 minutes that detects product with this defect.The chemistry leakage is visual upon opening the wrap.There are specific product use instructions on the carton, pouch film and insert stating, "do not use if the heat cell contents leak and/or wrap is damaged or torn"; therefore, this investigation recommends no further actions to be taken for batch x17277.Conclusion: the most probable root cause of this event is method/document doesn't exist.This defect could occur after the splice broke out (came apart) of the web on (b)(6)2018.The re-taping of the web that created a gathered up (bunched up) web misaligned the die registration optics when it passed between the optics.This splice should be assisted (move away) by the manufacturing technician to prevent physical contact with the registration optics.There is no procedure in place that provides instructions to manage this kind of splice.This is the most probable cause of this incident.No market action was determined for batch x17277 because this is the first complaint of this defect for this batch.At this time the defect is considered to be an isolated event for batch x17277.No additional batches have been impacted by this incident.The chemistry leakage from cut cells is visible upon opening the wrap and there are specific product use instructions on the carton, pouch film and insert stating, "do not use if the heat cell contents leak and/or wrap is damaged or torn".Qa summary and impact: the most probable root cause is related to the wrap was cut by the die cutter after a splice caused a misalignment of the die registration optics.At this time the defect is considered to be an isolated event.Batch x17277 met all product release criteria that include the visual attribute inspection for "heat pack integrity" every 10 minutes that detects product with this defect.The chemistry leakage is visual upon opening the wrap.There are specific product use instructions on the carton, pouch film and insert stating, "do not use if the heat cell contents leak and/or wrap is damaged or torn"; therefore, this investigation recommends no further actions to be taken for batch x17277.Follow-up (03may2019): new information received from a contactable consumer via product quality complaints group included: investigation results.Follow-up (24jun2019): follow-up attempts are completed.No further information is expected.Follow-up (16sep2019): follow-up attempts are completed.No further information is expected.Follow-up (30sep2019): follow-up attempts are completed.No further information is expected.Amendment: this follow-up report is being submitted to amend previously reported information: device medwatch information (evaluation codes) updated.Company clinical evaluation comment : the device malfunction from the returned sample has been confirmed.This malfunction has been identified prior to use of the device and the consumer did not use the device.No adverse event was associated with the use of the device.This single event malfunction has a theoretical risk to cause skin burn.The review of the lot/batch records does not suggest a quality issue related to the manufacture of this lot; the defect considered was an isolated event for batch x17277.No further investigations or actions are suggested at this time., comment: the device malfunction from the returned sample has been confirmed.This malfunction has been identified prior to use of the device and the consumer did not use the device.No adverse event was associated with the use of the device.This single event malfunction has a theoretical risk to cause skin burn.The review of the lot/batch records does not suggest a quality issue related to the manufacture of this lot; the defect considered was an isolated event for batch x17277.No further investigations or actions are suggested at this time.
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Event Description
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Event verbatim [preferred term] both wraps were not cut properly and the black stuff was falling out of the pouches [device leakage], narrative: the initial case was missing the following minimum criteria: no indication the consumer experienced an adverse event under thermacare, only a product complaint.Upon receipt of follow-up information on 25nov2018, this case now contains all required information to be considered valid.This is a spontaneous report from a contactable consumer.A patient of unspecified age and gender started to use thermacare heatwrap (thermacare lower back & hip) (device lot number x17277, expiration date apr2021) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.On an unspecified date, the patient reported they purchased a defective box of thermacare heatwraps.They stated both wraps were not cut properly and the black stuff was falling out of the pouches on the bottom row.Both were un-useable.The patient had pictures of both wraps.Action taken with the suspect product was unknown.Clinical outcome of the event was unknown.Additional information received from product quality complaint (pqc) group included investigation results.Sample evaluation: photos were attached in pcom.Photos show two lbh wraps with cell packs cut and leaking chemistry to outside of wrap.One photo shows the carton with coding: (l) x17277 may2017 exp apr2021 01:33.Site investigation #: (b)(4); severity rank: s3; device malfunction confirmed per (b)(4) bridging pfizer hal severity numbers applied in the thermacare heatwrap rmp, effective 28sep2018, version 1.0 # 1.1.1.1 potential hazard - skin burn, d2.2.2.1-die cut cell, severity rank s3.Initial complaint assessment: batch x17277 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of retain samples included five cartons, 10 pouches and the 10 wraps inside.Inspection shows no obvious defects to cartons, pouches or wraps.(b)(4) retain sample inspection form documented the retain evaluation performed on 27nov2018.An evaluation of the complaint history confirms that this is the first complaint for the sub class cells damaged/leaking for this batch.On the basis of this evaluation, a trend does not exist for this batch.The pcom search returned a total of 40 complaints for lower back and hip (lbh) products during this time period for the class/subclass.Of the 40 complaints; 12 complaints have batch number recorded as "unknown".The 28 remaining complaints were evaluated.Five of the 28 records were identified as having a manufacturing related root cause of the wrap having cells/damaged/ leaking defects.Scope / impact analysis: batch x17277 is within the scope of this investigation.No additional batches have been impacted by this incident.Assessment of the thermacare heatwraps hazards associated to the product defect under investigation was performed per(b)(4)"bridging pfizer hal severity ranking to severity numbers applied in the thermacare heatwrap rmp", version 1.0, effective date: 28sep2018.This complaint was for cut cells on the lbh heat wrap and it is a confirmed device malfunction.Severity level: s3 (serious).Potential hazard id: 1.1.1.1.Potential hazard: individual cell too hot.Potential cause id: it is not included in (b)(4).A commitment will be generated to update (b)(4).Potential cause-failure mechanism description: it is not included in (b)(4).A commitment will be generated to update (b)(4).This batch was manufactured from 14may2018 to 17may2018 and was released to market on 24may2018.The batch is composed of (b)(4) wraps packaged into a 2 count configuration.The cut cells were caused by a potential die registration optics misalignment scenario created by an unassisted carrier web (uws0) splice that made physical contact with the optics.During batch x17277 manufacturing there was a visual attribute inspection for "heat pack integrity" 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 two defective wraps of the (b)(4) 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.The chemistry leakage is visual upon opening the wrap.There are specific product use instructions on the carton, pouch film and insert stating, "do not use if the heat cell contents leak and/or wrap is damaged or torn".There is no trend for this batch related to cells damaged/leaking per site procedures.Retained samples (10 heatwraps) were reviewed and did not identify any defect.Correction: the wraps with cut cells allowing to the premix chemistry coming out of the cells (leaking) were caused by a potential misaligned of the die registration optics.Batch x17277 was release on 24may2018 and (b)(4) wraps were manufactured.This is the first complaint for batch x17277 related to cut cell wraps allowing to the premix chemistry coming out of the cells.At this time the defect is considered to be an isolated event.Batch x17277 met all product release criteria that include the visual attribute inspection for "heat pack integrity" every 10 minutes that detects product with this defect.The chemistry leakage is visual upon opening the wrap.There are specific product use instructions on the carton, pouch film and insert stating, "do not use if the heat cell contents leak and/or wrap is damaged or torn"; therefore, this investigation recommends no further actions to be taken for batch x17277.Preventive actions: corrective actions: commitment (b)(4) was issued to re-classified the b and m line die cutter infeed conveyor vacuum centerline from non-critical to critical.The set points should be defined.If the risk assessment asmt-24946 "centerline risk assessment" is impacted with this change it should be updated.An effectiveness check (ec) record will be generated after the reclassification of b-line die cutter infeed conveyor vacuum centerline from non-critical to critical.The ec will monitor any incident of cut cells related to this centerline parameter.The timeframe to perform the ec will be 1 year after the effective date of the change.The deliverable is to generate a qts investigations query report for batches produced after the effective date of the change.The criteria for ec is zero events of cut cells related to die cutter infeed conveyor vacuum centerline.Commitment (b)(4) was issued to create a procedure to manage the splice broke outs (came apart) on carrier web (uws0) where the re-taping of the web created to resume production should be walked down to ensure it doesn't travel through the registration optics and change its position.An effectiveness check (ec) record will be generated after procedure effective date.The ec will monitor any incident of cut cells related to this process.The timeframe to perform the ec will be 1 year after the effective date of this procedure implementation.The deliverable is to generate a qts investigations query report for batches produced after the effective date of the change.The criteria for ec is zero events of cut cells related to splice broke outs incidents.Commitment (b)(4) was issued to install a camera inspection system to detect and reject defective product from b-line including wraps with cut cells.An effectiveness check (ec) record will be generated after camera implementation date.The ec will monitor any incident of cut cells.The timeframe to perform the ec will be 1 year after the camera implementation.The deliverable is to generate a qts investigations query report for batches produced after the effective date of the change.The criteria for ec is zero events related to cut cells defect.Commitment (b)(4) was issued to update (b)(4) "hazard analysis, thermacare heat wrap product: 8 and 12 hour", version 5.0.The new version will include the potential cause id and the potential cause-failure mechanism description related to the die registration optics misaligned scenario.No effectiveness check (ec) record is required for this action since it was originated to update (b)(4).This action was not created to prevent recurrence of the cut cells defect.Commitment (b)(4) was issued to update (b)(4) "process failure mode and effect analysis", v.6.0 effective date 04 feb 2019.The new version will include the cause id and the potential cause-failure mechanism related to the die registration optics misaligned scenario.No effectiveness check (ec) record is required for this action since it was originated to update (b)(4).This action was not created to prevent recurrence of the cut cells defect.Commitment (b)(4) was issued to update sop-99871 "b/m line converting rotary die cutter registration (operating window) set-up mwi", v.2.0 effective date 01-mar-2019.The change will include instructions to open the cull station during the die cutter registration adjustments.An effectiveness check (ec) record will be generated after procedure effective date.The ec will monitor any incident of cut cells related to this process.The timeframe to perform the ec will be 1 year after the effective date of this procedure implementation.The deliverable is to generate a qts investigations query report for batches produced after the effective date of the change.The criteria for ec is zero events of cut cells related to die cutter registration set-up or adjustments.Conclusion: the most probable root cause of this event is method/document doesn't exist.This defect could occur after the splice broke out (came apart) of the web on (b)(6) 2018.The re-taping of the web that created a gathered up (bunched up) web misaligned the die registration optics when it passed between the optics.This splice should be assisted (move away) by the manufacturing technician to prevent physical contact with the registration optics.There is no procedure in place that provides instructions to manage this kind of splice.This is the most probable cause of this incident.No market action was determined for batch x17277 because this is the first complaint of this defect for this batch.At this time the defect is considered to be an isolated event for batch x17277.No additional batches have been impacted by this incident.The chemistry leakage from cut cells is visible upon opening the wrap and there are specific product use instructions on the carton, pouch film and insert stating, "do not use if the heat cell contents leak and/or wrap is damaged or torn".Qa summary and impact: the most probable root cause is related to the wrap was cut by the die cutter after a splice caused a misalignment of the die registration optics.At this time the defect is considered to be an isolated event.Batch x17277 met all product release criteria that include the visual attribute inspection for "heat pack integrity" every 10 minutes that detects product with this defect.The chemistry leakage is visual upon opening the wrap.There are specific product use instructions on the carton, pouch film and insert stating, "do not use if the heat cell contents leak and/or wrap is damaged or torn"; therefore, this investigation recommends no further actions to be taken for batch x17277.Site sample status: not received.Follow-up (03may2019): new information received from a contactable consumer via product quality complaints group included: investigation results.Follow-up (24jun2019): follow-up attempts are completed.No further information is expected.Follow-up (16sep2019): follow-up attempts are completed.No further information is expected.Follow-up (30sep2019): follow-up attempts are completed.No further information is expected.Amendment: this follow-up report is being submitted to amend previously reported information: device medwatch information (evaluation codes) updated.Follow-up (25aug2020): follow-up attempts are completed.No further information is expected.Follow-up (18nov2020): follow-up attempts are completed.No further information is expected.Amendment: this follow-up report is being submitted to amend previously reported information: adverse event was unchecked and preventive action added.
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Manufacturer Narrative
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Sample evaluation: photos were attached in pcom.Photos show two lbh wraps with cell packs cut and leaking chemistry to outside of wrap.One photo shows the carton with coding: (l) x17277 may2017 exp apr2021 01:33.Site investigation #: (b)(4); severity rank: s3; device malfunction confirmed per (b)(4)bridging pfizer hal severity numbers applied in the thermacare heatwrap rmp, effective 28sep2018, version 1.0 # 1.1.1.1 potential hazard - skin burn, d2.2.2.1-die cut cell, severity rank s3.Initial complaint assessment: batch x17277 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of retain samples included five cartons, 10 pouches and the 10 wraps inside.Inspection shows no obvious defects to cartons, pouches or wraps.(b)(4) retain sample inspection form documented the retain evaluation performed on 27nov2018.An evaluation of the complaint history confirms that this is the first complaint for the sub class cells damaged/leaking for this batch.On the basis of this evaluation, a trend does not exist for this batch.The pcom search returned a total of 40 complaints for lower back and hip (lbh) products during this time period for the class/subclass.Of the 40 complaints; 12 complaints have batch number recorded as "unknown".The 28 remaining complaints were evaluated.Five of the 28 records were identified as having a manufacturing related root cause of the wrap having cells/damaged/ leaking defects.Scope / impact analysis: batch x17277 is within the scope of this investigation.No additional batches have been impacted by this incident.Assessment of the thermacare heatwraps hazards associated to the product defect under investigation was performed per (b)(4) ¿bridging pfizer hal severity ranking to severity numbers applied in the thermacare heatwrap rmp¿, version 1.0, effective date: 28sep2018.This complaint was for cut cells on the lbh heat wrap and it is a confirmed device malfunction.Severity level: s3 (serious).Potential hazard id: 1.1.1.1.Potential hazard: individual cell too hot.Potential cause id: it is not included in (b)(4).A commitment will be generated to update (b)(4).Potential cause-failure mechanism description: it is not included in (b)(4).A commitment will be generated to update (b)(4).This batch was manufactured from 14may2018 to 17may2018 and was released to market on 24may2018.The batch is composed of (b)(4) wraps packaged into a 2 count configuration.The cut cells were caused by a potential die registration optics misalignment scenario created by an unassisted carrier web (uws0) splice that made physical contact with the optics.During batch x17277 manufacturing there was a visual attribute inspection for ¿heat pack integrity¿ 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 two defective wraps of the (b)(4) 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.The chemistry leakage is visual upon opening the wrap.There are specific product use instructions on the carton, pouch film and insert stating, ¿do not use if the heat cell contents leak and/or wrap is damaged or torn¿.There is no trend for this batch related to cells damaged/leaking per site procedures.Retained samples (10 heatwraps) were reviewed and did not identify any defect.Correction: the wraps with cut cells allowing to the premix chemistry coming out of the cells (leaking) were caused by a potential misaligned of the die registration optics.Batch x17277 was release on 24may2018 and (b)(4) wraps were manufactured.This is the first complaint for batch x17277 related to cut cell wraps allowing to the premix chemistry coming out of the cells.At this time the defect is considered to be an isolated event.Batch x17277 met all product release criteria that include the visual attribute inspection for ¿heat pack integrity¿ every 10 minutes that detects product with this defect.The chemistry leakage is visual upon opening the wrap.There are specific product use instructions on the carton, pouch film and insert stating, ¿do not use if the heat cell contents leak and/or wrap is damaged or torn¿; therefore, this investigation recommends no further actions to be taken for batch x17277.Conclusion: the most probable root cause of this event is method/document doesn¿t exist.This defect could occur after the splice broke out (came apart) of the web on (b)(6) 2018.The re-taping of the web that created a gathered up (bunched up) web misaligned the die registration optics when it passed between the optics.This splice should be assisted (move away) by the manufacturing technician to prevent physical contact with the registration optics.There is no procedure in place that provides instructions to manage this kind of splice.This is the most probable cause of this incident.No market action was determined for batch x17277 because this is the first complaint of this defect for this batch.At this time the defect is considered to be an isolated event for batch x17277.No additional batches have been impacted by this incident.The chemistry leakage from cut cells is visible upon opening the wrap and there are specific product use instructions on the carton, pouch film and insert stating, ¿do not use if the heat cell contents leak and/or wrap is damaged or torn¿.Qa summary and impact: the most probable root cause is related to the wrap was cut by the die cutter after a splice caused a misalignment of the die registration optics.At this time the defect is considered to be an isolated event.Batch x17277 met all product release criteria that include the visual attribute inspection for ¿heat pack integrity¿ every 10 minutes that detects product with this defect.The chemistry leakage is visual upon opening the wrap.There are specific product use instructions on the carton, pouch film and insert stating, ¿do not use if the heat cell contents leak and/or wrap is damaged or torn¿; therefore, this investigation recommends no further actions to be taken for batch x17277.Preventive actions: corrective actions: commitment (b)(4) was issued to re-classified the b and m line die cutter infeed conveyor vacuum centerline from non-critical to critical.The set points should be defined.If the risk assessment asmt-24946 "centerline risk assessment" is impacted with this change it should be updated.An effectiveness check (ec) record will be generated after the reclassification of b-line die cutter infeed conveyor vacuum centerline from non-critical to critical.The ec will monitor any incident of cut cells related to this centerline parameter.The timeframe to perform the ec will be 1 year after the effective date of the change.The deliverable is to generate a qts investigations query report for batches produced after the effective date of the change.The criteria for ec is zero events of cut cells related to die cutter infeed conveyor vacuum centerline.Commitment (b)(4) was issued to create a procedure to manage the splice broke outs (came apart) on carrier web (uws0) where the re-taping of the web created to resume production should be walked down to ensure it doesn't travel through the registration optics and change its position.An effectiveness check (ec) record will be generated after procedure effective date.The ec will monitor any incident of cut cells related to this process.The timeframe to perform the ec will be 1 year after the effective date of this procedure implementation.The deliverable is to generate a qts investigations query report for batches produced after the effective date of the change.The criteria for ec is zero events of cut cells related to splice broke outs incidents.Commitment (b)(4) was issued to install a camera inspection system to detect and reject defective product from b-line including wraps with cut cells.An effectiveness check (ec) record will be generated after camera implementation date.The ec will monitor any incident of cut cells.The timeframe to perform the ec will be 1 year after the camera implementation.The deliverable is to generate a qts investigations query report for batches produced after the effective date of the change.The criteria for ec is zero events related to cut cells defect.Commitment (b)(4) was issued to update (b)(4) "hazard analysis, thermacare heat wrap product: 8 and 12 hour", version 5.0.The new version will include the potential cause id and the potential cause-failure mechanism description related to the die registration optics misaligned scenario.No effectiveness check (ec) record is required for this action since it was originated to update (b)(4).This action was not created to prevent recurrence of the cut cells defect.Commitment (b)(4) was issued to update (b)(4) "process failure mode and effect analysis", v.6.0 effective date 04 feb 2019.The new version will include the cause id and the potential cause-failure mechanism related to the die registration optics misaligned scenario.No effectiveness check (ec) record is required for this action since it was originated to update (b)(4).This action was not created to prevent recurrence of the cut cells defect.Commitment (b)(4) was issued to update sop-99871 "b/m line converting rotary die cutter registration (operating window) set-up mwi", v.2.0 effective date 01-mar-2019.The change will include instructions to open the cull station during the die cutter registration adjustments.An effectiveness check (ec) record will be generated a.
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