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| Lot Number X41714 |
| Device Problems
Material Fragmentation (1261); Component Missing (2306); 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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Event Description
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One wrap with black particles coming out of it [device leakage] ,.Case narrative:the initial case was missing the following minimum criteria: only a product complaint without associated adverse event or other reportable information.Upon receipt of follow-up information on (b)(6) 2020, this case now contains all required information to be considered valid.This is a spontaneous report from a contactable pharmacist.A male patient of an unspecified age started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number x41714, from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.The pharmacist reported that a consumer returned a unit of thermacare heatwrap with one wrap with black particles coming out of it.The consumer found the product with black particles and didn't apply it on the skin.The action taken with thermacare heatwrap was unknown.The outcome of the event was unknown.The severity of harm has been selected by the manufacturing site as s3.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the available information, the patient reported one wrap with black particles coming out of it, which represents a potential device malfunction.No adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.The event is 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 one wrap with black particles coming out of it, which represents a potential device malfunction.No adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.The event is 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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Event verbatim [preferred term] one wrap with black particles coming out of it [device leakage] ,.Case narrative:the initial case was missing the following minimum criteria: only a product complaint without associated adverse event or other reportable information.Upon receipt of follow-up information on 09jan2020, this case now contains all required information to be considered valid.This is a spontaneous report from a contactable pharmacist.A male patient of an unspecified age started to use thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number x41714, from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.The pharmacist reported that a consumer returned a unit of thermacare heatwrap with one wrap with black particles coming out of it.The consumer found the product with black particles and didn't apply it on the skin.The action taken with thermacare heatwrap was unknown.The outcome of the event was unknown.The severity of harm has been selected by the manufacturing site as s3.Additional information from the from the product quality complaint group was as follows.Conclusion: although the complaint sub-class for this event was cells damaged/leaking, the cell damage observed on the complaint sample wrap is not typical of cell damage that would occur during the wrap manufacturing process.Instead, the complaint sample wrap displays what appears to be torn cells.It was concluded that the cells of the returned complaint sample wrap were torn by the consumer while attempting to identify what the red appearance (manufacturer splice tape) was within the wrap.The sca material was peeled back from the bottom sheet causing the cells to be torn.Pieces of the bottom sheet are visible on the sca of the returned complaint sample wrap in the same locations as the torn cells of the cell pack.Inspection of the complaint sample wrap shows that the manufacturer splice was not applied across the entire width of the sca material.Images taken during walking the process for root cause analysis reveal the potential for splices to not be rejected if they are too short to be conveyed through the splice detector.This is most likely what occurred during the production of the complaint sample wrap.The most probable root cause for this incident was categorized as (tier1) material, (tier2) supplier quality issue because the manufacturer splice tape was too short to be conveyed through the splice detector and was not rejected from the line.Follow-up (10mar2020).New information received from the product quality complaint group included: investigation results.No follow-up attempts are needed.No further information is expected., comment: based on the available information, the patient reported one wrap with black particles coming out of it, which represents a potential device malfunction.No adverse event was associated with the use of the device.This is a single potential device malfunction which has a theoretical risk to cause skin burn.The event is medically assessed as associated with the use of the device.The company conducted an investigation, and the most probable root cause for this event was categorized as (tier1) material, (tier2) supplier quality issue.There is not a complaint trend for any class(es) associated to the suggested key product complaints database terms.No further investigations or actions are suggested at this time.
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Manufacturer Narrative
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Conclusion: although the complaint sub-class for this event was cells damaged/leaking, the cell damage observed on the complaint sample wrap is not typical of cell damage that would occur during the wrap manufacturing process.Instead, the complaint sample wrap displays what appears to be torn cells.It was concluded that the cells of the returned complaint sample wrap were torn by the consumer while attempting to identify what the red appearance (manufacturer splice tape) was within the wrap.The sca material was peeled back from the bottom sheet causing the cells to be torn.Pieces of the bottom sheet are visible on the sca of the returned complaint sample wrap in the same locations as the torn cells of the cell pack.Inspection of the complaint sample wrap shows that the manufacturer splice was not applied across the entire width of the sca material.Images taken during walking the process for root cause analysis reveal the potential for splices to not be rejected if they are too short to be conveyed through the splice detector.This is most likely what occurred during the production of the complaint sample wrap.The most probable root cause for this incident was categorized as (tier1) material, (tier2) supplier quality issue because the manufacturer splice tape was too short to be conveyed through the splice detector and was not rejected from the line.
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Manufacturer Narrative
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Summary of investigation: batch x41714 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Root cause/capa: process related was no.Final confirmation status was confirmed.Root cause analysis/identification: the root cause of this incident is (tier1) material, (tier2) supplier quality issue.The manufacturer splice tape was not long enough to pass through the splice detector, and therefore; the splice was not rejected.The cells of the wrap were damaged by the consumer examining the wrap to determine what the splice tape was.On (b)(6) 2020, the complaint sample wrap was inspected by greg west (gw) (hpm sme) and paul blanding (pb) (production technician).The edge of the manufacturer splice tape observed on the complaint sample wrap was approximately 30 mm from the drive side edge of the wrap (see attachment #1).This confirms that the manufacturer splice tape was not applied across the entire width of the material.Splice tape applied by thermacare production technicians would have covered the entire width of the wrap.Training for thermacare production technicians illustrates that splice tape is to be applied across the entire width of the material (see attachment #2).Placing the splice tape across the entire width of the material applies when setting up the splice at all off-line unwind stands.If the splice tape is not long enough it has the potential to not be conveyed through the splice detector, and therefore; the splice will not be rejected.It was agreed upon that the manufacturer splice tape was mostly like not rejected because the tape was not applied across the entire width of the material and was not long enough to be conveyed through the splice sensor.On (b)(6) 2020, images were taken (see attachment #3 and attachment #4) to see the distance from the edge of a wrap to the location of the uws0 splice detector.The green dot seen on the web is the location of the splice detector.The reference mark (pen mark) used for this image was marked at 30mm from the edge of the wrap because that was the distant the splice tape was from the edge of the complaint sample wrap.It is observed that the reference mark is close to the location of the splice detector.The compliant sample wrap was from the drive side of the web.The splice detector is located on the operator side of the web.The exact location of the splice tape for the operator side wrap produced along side the complaint sample wrap is not known.However, it can be seen that the splice tape has a potential to miss the splice detector depending on how the manufacturer applies the tape during the production of the sca material.In this incident, it is mostly likely that the splice tape on the operator side was too short and was not conveyed through the splice detector.One of the requirements for manufacturer splices per spec-25621 nsw/mj sca laminate 679mm r000006147 is that the splice be marked with red tape across the whole web width.The manufacturer splicer tape in this incident was not across the entire width of the web.It was also noticed and agreed upon that the damage to the heat cells in this incident appears to have occurred as the consumer peeled back the sca material to see what the splice tape was.There are pieces of the bottom sheet stuck to the sca in the same locations as the torn cells on the cell pack.(see attachment #5).To recreate this scenario, the sca was peeled back on a nsw wrap.The bottom sheet stuck to the sca causing the cell to be torn as was the case in the complaint sample wrap.(see attachment #6).For this incident, it was determined that the heat cells damaged/leaking was not a thermacare manufacturing related defect, but rather an attempt by the consumer to identify what the red appearance (manufacturer splice tape) was within the wrap.Therefore, the root cause is material/supplier quality issue.Rpt-39239 process failure mode and effect analysis (version 7.0, effective date 23-jul-2019) was reviewed for this incident.Rpt-39239 lists a potential failure mode of foreign objects in wrap.The potential effect is potential skin reaction (allergy or chemical sensitivity).The mitigation control(s): quality control are cil, hygiene procedure/food beverage (b)(4).The mitigation inspection is (1-3) the in-process variable and attribute quality checks.The foreign object in this incident was manufacturer splice tape.The splice detectors are an engineered mitigation for splice tape, and they are effective.However, in this incident the supplier quality issue of the splice tape not meeting requirements caused the manufacturer splice not to be rejected.Corrective action: (b)(4) was generated to contact the supplier of the sca material to follow-up on the length of manufacturer splices.Preventive action: there are no preventive actions as this event has already occurred and any actions at this point would be classified as corrective actions.Conclusion: although the complaint sub-class for this event was cells damaged/leaking, the cell damage observed on the complaint sample wrap is not typical of cell damage that would occur during the wrap manufacturing process.Instead, the complaint sample wrap displays what appears to be torn cells.It was concluded that the cells of the returned complaint sample wrap were torn by the consumer while attempting to identify what the red appearance (manufacturer splice tape) was within the wrap.The sca material was peeled back from the bottom sheet causing the cells to be torn.Pieces of the bottom sheet are visible on the sca of the returned complaint sample wrap in the same locations as the torn cells of the cell pack.Inspection of the complaint sample wrap shows that the manufacturer splice was not applied across the entire width of the sca material.Images taken during walking the process for root cause analysis reveal the potential for splices to not be rejected if they are too short to be conveyed through the splice detector.This is most likely what occurred during the production of the complaint sample wrap.The most probable root cause for this incident was categorized as (tier1) material, (tier2) supplier quality issue because the manufacturer splice tape was too short to be conveyed through the splice detector and was not rejected from the line.Form 46559 material incident form was initiated for this incident.(b)(4) has been generated to follow up with the supplier of the sca material concerning the length of manufacturer splices.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the second complaint for the sub class cells damaged/leaking received at the albany site requiring an evaluation for this batch.The previous complaint received at the site was not confirmed to have a manufacturing root cause related to the complaint.The complaint was evaluated to identify any potential trend.The calculated complaints per million produced (cpmp) result of 31 was above the upper control limit (ucl) of 14 complaints per million produced per (b)(4) , complaint trending guideline, effective 19-nov-2019.Per (b)(4), complaint trending guideline, effective, 19-nov-2019, a visual evaluation was performed to identify a potential trend for the lot and subclass.A trend was not identified.Refer to attachment heat cell damaged-leaking x41714.On the basis of this evaluation; a trend does not exist for this batch.Expedite trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass.Based on this citi customizable search, there is not a trend identified for the subclass of cells/damaged/leaking defects.Refer to the attached 36 month trend chart attached nsw8hr heat cell damaged-leaking nsw 8hr 07-jan-2017 to 07-jan-2020.This investigation was reopened on 07-oct-2020 to change information in the lot trend assessment & rationale and expedite trend assessment & rationale sections.This change was due to a deviation found from (b)(4), complaint trending guidelines, effective dates 19-nov-2019 and 24-feb-2020.A notification of nonconformance was opened action item (b)(4) , investigation (b)(4).This deviation will not change the root cause of the investigation.The samples were received on 27jan2020.Return sample evaluation: 2 wraps: one wrap is inside sealed pouch.Opened pouch to inspect wrap.No obvious defects.One wrap has splice tape under sca laminate.Sca laminate layer has been torn from wrap, damaging cell packs, allowing chemistry to leak out.2 pouches: x41714 s 11/15 2021-10 00:00 one pouch opened by consumer.One sealed.No obvious defects.1 carton: x41714 11/14 2021-10 23:59 carton is opened by consumer.
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Event Description
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Event verbatim [preferred term] one wrap with black particles coming out of it [device leakage], , narrative: the initial case was missing the following minimum criteria: only a product complaint without associated adverse event or other reportable information.Upon receipt of follow-up information on 09jan2020, this case now contains all required information to be considered valid.This is a spontaneous report from a contactable pharmacist.A male patient of an unspecified age started to use thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number x41714, expiration date oct2021, from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.The pharmacist reported that the patient returned a unit of thermacare heatwrap with one wrap with black particles coming out of it.The patient found the product with black particles and didn't apply it on the skin.The action taken with thermacare heatwrap was unknown.The outcome of the event was unknown.The severity of harm has been selected by the manufacturing site as s3.Additional information from the from the product quality complaint group was as follows.Summary of investigation: batch x41714 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Root cause/capa: process related was no.Final confirmation status was confirmed.Root cause analysis/identification: the root cause of this incident is (tier1) material, (tier2) supplier quality issue.The manufacturer splice tape was not long enough to pass through the splice detector, and therefore; the splice was not rejected.The cells of the wrap were damaged by the consumer examining the wrap to determine what the splice tape was.On (b)(6) 2020, the complaint sample wrap was inspected by greg west (gw) (hpm sme) and paul blanding (pb) (production technician).The edge of the manufacturer splice tape observed on the complaint sample wrap was approximately 30 mm from the drive side edge of the wrap (see attachment #1).This confirms that the manufacturer splice tape was not applied across the entire width of the material.Splice tape applied by thermacare production technicians would have covered the entire width of the wrap.Training for thermacare production technicians illustrates that splice tape is to be applied across the entire width of the material (see attachment #2).Placing the splice tape across the entire width of the material applies when setting up the splice at all off-line unwind stands.If the splice tape is not long enough it has the potential to not be conveyed through the splice detector, and therefore; the splice will not be rejected.It was agreed upon that the manufacturer splice tape was mostly like not rejected because the tape was not applied across the entire width of the material and was not long enough to be conveyed through the splice sensor.On (b)(6) 2020, images were taken (see attachment #3 and attachment #4) to see the distance from the edge of a wrap to the location of the uws0 splice detector.The green dot seen on the web is the location of the splice detector.The reference mark (pen mark) used for this image was marked at 30mm from the edge of the wrap because that was the distant the splice tape was from the edge of the complaint sample wrap.It is observed that the reference mark is close to the location of the splice detector.The compliant sample wrap was from the drive side of the web.The splice detector is located on the operator side of the web.The exact location of the splice tape for the operator side wrap produced along side the complaint sample wrap is not known.However, it can be seen that the splice tape has a potential to miss the splice detector depending on how the manufacturer applies the tape during the production of the sca material.In this incident, it is mostly likely that the splice tape on the operator side was too short and was not conveyed through the splice detector.One of the requirements for manufacturer splices per spec-25621 nsw/mj sca laminate 679mm r000006147 is that the splice be marked with red tape across the whole web width.The manufacturer splicer tape in this incident was not across the entire width of the web.It was also noticed and agreed upon that the damage to the heat cells in this incident appears to have occurred as the consumer peeled back the sca material to see what the splice tape was.There are pieces of the bottom sheet stuck to the sca in the same locations as the torn cells on the cell pack.(see attachment #5).To recreate this scenario, the sca was peeled back on a nsw wrap.The bottom sheet stuck to the sca causing the cell to be torn as was the case in the complaint sample wrap.(see attachment #6).For this incident, it was determined that the heat cells damaged/leaking was not a thermacare manufacturing related defect, but rather an attempt by the consumer to identify what the red appearance (manufacturer splice tape) was within the wrap.Therefore, the root cause is material/supplier quality issue.Rpt-39239 process failure mode and effect analysis (version 7.0, effective date 23-jul-2019) was reviewed for this incident.Rpt-39239 lists a potential failure mode of foreign objects in wrap.The potential effect is potential skin reaction (allergy or chemical sensitivity).The mitigation control(s): quality control are cil, hygiene procedure/food beverage (b)(4).The mitigation inspection is (1-3) the in-process variable and attribute quality checks.The foreign object in this incident was manufacturer splice tape.The splice detectors are an engineered mitigation for splice tape, and they are effective.However, in this incident the supplier quality issue of the splice tape not meeting requirements caused the manufacturer splice not to be rejected.Corrective action: (b)(4) was generated to contact the supplier of the sca material to follow-up on the length of manufacturer splices.Preventive action: there are no preventive actions as this event has already occurred and any actions at this point would be classified as corrective actions.Conclusion: although the complaint sub-class for this event was cells damaged/leaking, the cell damage observed on the complaint sample wrap is not typical of cell damage that would occur during the wrap manufacturing process.Instead, the complaint sample wrap displays what appears to be torn cells.It was concluded that the cells of the returned complaint sample wrap were torn by the consumer while attempting to identify what the red appearance (manufacturer splice tape) was within the wrap.The sca material was peeled back from the bottom sheet causing the cells to be torn.Pieces of the bottom sheet are visible on the sca of the returned complaint sample wrap in the same locations as the torn cells of the cell pack.Inspection of the complaint sample wrap shows that the manufacturer splice was not applied across the entire width of the sca material.Images taken during walking the process for root cause analysis reveal the potential for splices to not be rejected if they are too short to be conveyed through the splice detector.This is most likely what occurred during the production of the complaint sample wrap.The most probable root cause for this incident was categorized as (tier1) material, (tier2) supplier quality issue because the manufacturer splice tape was too short to be conveyed through the splice detector and was not rejected from the line.Form (b)(4) material incident form was initiated for this incident.(b)(4) has been generated to follow up with the supplier of the sca material concerning the length of manufacturer splices.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the second complaint for the sub class cells damaged/leaking received at the albany site requiring an evaluation for this batch.The previous complaint received at the site was not confirmed to have a manufacturing root cause related to the complaint.The complaint was evaluated to identify any potential trend.The calculated complaints per million produced (cpmp) result of 31 was above the upper control limit (ucl) of 14 complaints per million produced per (b)(4), complaint trending guideline, effective 19-nov-2019.Per (b)(4), complaint trending guideline, effective, 19-nov-2019, a visual evaluation was performed to identify a potential trend for the lot and subclass.A trend was not identified.Refer to attachment heat cell damaged-leaking x41714.On the basis of this evaluation; a trend does not exist for this batch.Expedite trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass.Based on this citi customizable search, there is not a trend identified for the subclass of cells/damaged/leaking defects.Refer to the attached 36 month trend chart attached nsw8hr heat cell damaged-leaking nsw 8hr 07-jan-2017 to 07-jan-2020.This investigation was reopened on 07-oct-2020 to change information in the lot trend assessment & rationale and expedite trend assessment & rationale sections.This change was due to a deviation found from (b)(4), complaint trending guidelines, effective dates 19-nov-2019 and 24-feb-2020.A notification of nonconformance was opened action item (b)(4), investigation (b)(4).This deviation will not change the root cause of the investigation.The samples were received on 27jan2020.Return sample evaluation: 2 wraps: one wrap is inside sealed pouch.Opened pouch to inspect wrap.No obvious defects.One wrap has splice tape under sca laminate.Sca laminate layer has been torn from wrap, damaging cell packs, allowing chemistry to leak out.2 pouches: x41714 s 11/15 2021-10 00:00 one pouch opened by consumer.One sealed.No obvious defects.1 carton: x41714 11/14 2021-10 23:59 carton is opened by consumer.Follow-up (10mar2020).New information received from the product quality complaint group included: investigation results.No follow-up attempts are needed.No further information is expected.Follow-up (13oct2020): new information received from the product quality complaint group includes updated investigational results.No follow-up attempts are needed.No further information is expected.
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Search Alerts/Recalls
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