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| Lot Number T73713 |
| Device Problems
Leak/Splash (1354); Product Quality Problem (1506)
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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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Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass heat cells damaged/leaking.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Reasonably suggest device malfunction: yes.Severity of harm: s3.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following complaint intake, triage, and investigation (citi) customizable search was performed: scope: site notification date: 08/12/2016 through 08/012/2019/manufacturing site: (b)(4)/complaint class: product use.Attribute/ complaint sub class: heat cells damaged/leaking.The citi customizable search returned a total of 3 complaints for flexible use products during this time period for the class/subclass.None were confirmed to have a manufacturing process root cause for a complaint of heat cells damaged/leaking.The complaints were evaluated to identify any potential trend.The calculated complaints per million produced (cpmp) result of 32 complaints was above the upper control limit (ucl) of 14 complaints per (b)(4) "complaint trending guideline", effective 05 feb 2019.An evaluation of the 36 month trend chart did not show a significant increase over time.Exped trend actions taken: based on this citi customizable search, there is not a trend identified for the subclass of heat cells damaged/leaking for flexible use product, refer to attachment flexible use heat cells damaged leaking (b)(6) 2016 to (b)(6) 2019.
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Event Description
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One heat wrap had damaged heat cells where the content leaked/ little black crumbs on the floor [device leakage].Case narrative: this is a spontaneous report from a contactable consumer.A female patient of unknown age started to receive thermacare heatwrap (thermacare fuer flexible anwendung) from unknown date for unknown indication.Medical history and concomitant medications were not reported.The patient reported one heat wrap had damaged heat cells where the content leaked.The patient had been using the thermacare product again and again for years, again today.After a short while, she noticed little black crumbs on the floor in the apartment that she could not explain.After a stay in the bathroom she got the certainty that this was the content of her thermacare heatwrap.It's so badly processed that it got open in one place.The action taken in response to the event of the product was unknown.The outcome of the event was unknown.Additional information received from product quality complaint (pqc) group included investigation results.Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass heat cells damaged/leaking.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Reasonably suggest device malfunction: yes.Severity of harm: s3.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following complaint intake, triage, and investigation (citi) customizable search was performed: scope: site notification date: 08/12/2016 through 08/012/2019/manufacturing site: (b)(4)/complaint class: product use.Attribute/ complaint sub class: heat cells damaged/leaking.The citi customizable search returned a total of 3 complaints for flexible use products during this time period for the class/subclass.None were confirmed to have a manufacturing process root cause for a complaint of heat cells damaged/leaking.The complaints were evaluated to identify any potential trend.The calculated complaints per million produced (cpmp) result of 32 complaints was above the upper control limit (ucl) of 14 complaints per (b)(4)"complaint trending guideline", effective 05 feb 2019.An evaluation of the 36 month trend chart did not show a significant increase over time.Exped trend actions taken: based on this citi customizable search, there is not a trend identified for the subclass of heat cells damaged/leaking for flexible use product, refer to attachment flexible use heat cells damaged leaking (b)(6) 2016 to (b)(6) 2019.There is no further action required., comment: based on the available information, the patient reported that "one heat wrap had damaged heat cells where the content leaked/ little black crumbs on the floor".There was "no adverse event" such as burn 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 was assessed as associated with the use of the device.There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.Product effect varies with each individual.No remedial action/corrective action/field safety corrective action is suggested at this time.
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Manufacturer Narrative
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Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass heat cells damaged/leaking.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Reasonably suggest device malfunction: yes.Severity of harm: s3.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following complaint intake, triage, and investigation (citi) customizable search was performed: scope: site notification date: 08/12/2016 through 08/012/2019/manufacturing site: pfizer albany/complaint class: product use.Attribute/ complaint sub class: heat cells damaged/leaking.The citi customizable search returned a total of 3 complaints for flexible use products during this time period for the class/subclass.None were confirmed to have a manufacturing process root cause for a complaint of heat cells damaged/leaking.The complaints were evaluated to identify any potential trend.The calculated complaints per million produced (cpmp) result of 32 complaints was above the upper control limit (ucl) of 14 complaints per sop-105746 "complaint trending guideline", effective 05 feb 2019.An evaluation of the 36 month trend chart did not show a significant increase over time.Exped trend actions taken: based on this citi customizable search, there is not a trend identified for the subclass of heat cells damaged/leaking for flexible use product, refer to attachment flexible use heat cells damaged leaking 08-12-2016 to 08-12-2019.There is no fur.
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Event Description
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One heat wrap had damaged heat cells where the content leaked/little black crumbs on the floor/the content of the heat wrap leaked [device leakage].Case narrative: this is a spontaneous report from a contactable consumer.A 65-year-old female patient started to receive thermacare heatwrap (thermacare fuer flexible anwendung), lot number: t73713, expiration date: 31aug2020, from unknown date for unknown indication.Medical history and concomitant medications were not reported.The patient reported one heat wrap had damaged heat cells where the content leaked.The patient had been using the thermacare product again and again for years, again today.After a short while, she noticed little black crumbs on the floor in the apartment that she could not explain.After a stay in the bathroom she got the certainty that this was the content of her thermacare heatwrap.It's so badly processed that it got open in one place.It was further reported that the product was not available anymore.The patient did not require hospitalization and did not receive treatment for the content of the heat wrap leaked.No harm to the patient was caused, only her clothes and the flat were dirty.The action taken in response to the event of the product was unknown.The outcome of the event was unknown.Additional information received from product quality complaint (pqc) group included investigation results.Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass heat cells damaged/leaking.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Reasonably suggest device malfunction: yes.Severity of harm: s3.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following complaint intake, triage, and investigation (citi) customizable search was performed: scope: site notification date: 08/12/2016 through 08/012/2019/manufacturing site: pfizer albany/complaint class: product use.Attribute/ complaint sub class: heat cells damaged/leaking.The citi customizable search returned a total of 3 complaints for flexible use products during this time period for the class/subclass.None were confirmed to have a manufacturing process root cause for a complaint of heat cells damaged/leaking.The complaints were evaluated to identify any potential trend.The calculated complaints per million produced (cpmp) result of 32 complaints was above the upper control limit (ucl) of 14 complaints per sop-105746 "complaint trending guideline", effective 05 feb 2019.An evaluation of the 36 month trend chart did not show a significant increase over time.Exped trend actions taken: based on this citi customizable search, there is not a trend identified for the subclass of heat cells damaged/leaking for flexible use product, refer to attachment flexible use heat cells damaged leaking 08-12-2016 to 08-12-2019.There is no further action required.Follow-up (19aug2019 and 03sep2019): new information received from a contactable consumer includes patient age, device data (lot number and expiration date), deny of hospitalization, deny of treatment and event details.Follow-up attempts are completed.No further information is expected., comment: based on the available information, the patient reported that "one heat wrap had damaged heat cells where the content leaked/ little black crumbs on the floor".There was "no adverse event" such as burn 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 was assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No remedial action/corrective action/field safety corrective action is suggested at this time.
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Manufacturer Narrative
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Conclusion: the most probable root cause for this incident was classified under method / procedure (document unclear/lacking details).The return sample confirmed the wrap has stray chemistry leaking from cell pack to outside of wrap.A full investigation was conducted on a similar complaint (3772617).The cell pack is manufactured at the heat pack maker (hpm) on the thermacare b line.The non-aperture bottom film is the material where the cell pack is formed via vacuum force and loaded with the chemistry premix.After the chemistry addition, the cells are dosed with the brine solution.Then, the top film is added over the bottom film and they are heat sealed when the cell pack web is conveyed through the seal roll.Corrective action: during version 6.0 of sop-63921 equipment cleaning, inspection and lubrication (cil) procedure effective date 31jan2018 the seal roll routine cleaning was implemented as part of process improvement initiative.The seal roll cleaning procedure is classified under high priority category during the production shifts transitions.Version 11.0 effective date 27 feb 2019 included additional instructions for seal roll cleaning process after top and bottom films mistracking events per manufacturing investigation (b)(4).The effectiveness check (b)(4) close on 26 jul 2019 did not report additional incidents related to build up on the seal roll.This procedure updates were completed after the production of batch t48946.No additional actions are recommended.This corrective action was also implemented on b-line.Our manufacturing operations employ quality control procedures which include in-process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within.
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Event Description
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Event verbatim [preferred term] one heat wrap had damaged heat cells where the content leaked/little black crumbs on the floor [device leakage].Case narrative:this is a spontaneous report from a contactable consumer.A 65-year-old female patient started to receive thermacare heatwrap (thermacare fuer flexible anwendung), lot number t73713, expiration date 31aug2020, from unknown date for unknown indication.Medical history and concomitant medications were not reported.The patient reported one heat wrap had damaged heat cells where the content leaked.The patient had been using the thermacare product again and again for years, again today, on (b)(6) 2019.After a short while, she noticed little black crumbs on the floor in the apartment that she could not explain.After a stay in the bathroom she got the certainty that this was the content of her thermacare heatwrap.It's so badly processed that it got open in one place.The patient did not require hospitalization and did not receive treatment for the content of the heat wrap leaked.No harm to the patient was caused, only her clothes and the flat were dirty.This only happened once.The action taken in response to the event of the product was unknown.The outcome of the event was unknown.As of 19nov2019, additional information received from product quality complaint (pqc) group included investigation results.Conclusion: the most probable root cause for this incident was classified under method / procedure (document unclear/lacking details).The return sample confirmed the wrap has stray chemistry leaking from cell pack to outside of wrap.A full investigation was conducted on a similar complaint (3772617).The cell pack is manufactured at the heat pack maker (hpm) on the thermacare b line.The non-aperture bottom film is the material where the cell pack is formed via vacuum force and loaded with the chemistry premix.After the chemistry addition, the cells are dosed with the brine solution.Then, the top film is added over the bottom film and they are heat sealed when the cell pack web is conveyed through the seal roll.Corrective action: during version 6.0 of sop-63921 equipment cleaning, inspection and lubrication (cil) procedure effective date 31jan2018 the seal roll routine cleaning was implemented as part of process improvement initiative.The seal roll cleaning procedure is classified under high priority category during the production shifts transitions.Version 11.0 effective date 27feb2019 included additional instructions for seal roll cleaning process after top and bottom films mistracking events per manufacturing investigation (b)(4).The effectiveness check (b)(4) close on 26jul2019 did not report additional incidents related to build up on the seal roll.This procedure updates were completed after the production of batch t48946.No additional actions are recommended.This corrective action was also implemented on b-line.Our manufacturing operations employ quality control procedures which include in-process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Severity rank was assessed as s3.Follow-up (19aug2019 and 03sep2019): new information received from a contactable consumer includes patient age, device data (lot number and expiration date), deny of hospitalization, deny of treatment and event details.Follow-up (05nov2019): new information received from a contactable consumer includes: event data (onset date added).Follow-up attempts are completed.No further information is expected.Follow-up (19nov2019): new information received from the product quality complaint group includes investigation results of the returned sample and severity rank.Follow-up attempts are completed.No further information is expected., comment: based on the available information, the patient reported that "one heat wrap had damaged heat cells where the content leaked/ little black crumbs on the floor".There was "no adverse event" such as burn 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 was assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No remedial action/corrective action/field safety corrective action is suggested at this time.
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Event Description
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One heat wrap had damaged heat cells where the content leaked/little black crumbs on the floor [device leakage].Case narrative: this is a spontaneous report from a contactable consumer.A 65-year-old female patient started to receive thermacare heatwrap (thermacare fuer flexible anwendung), lot number: t73713, expiration date: 31aug2020, from unknown date for unknown indication.Medical history and concomitant medications were not reported.The patient reported one heat wrap had damaged heat cells where the content leaked.The patient had been using the thermacare product again and again for years, again today, on (b)(6) 2019.After a short while, she noticed little black crumbs on the floor in the apartment that she could not explain.After a stay in the bathroom she got the certainty that this was the content of her thermacare heatwrap.It's so badly processed that it got open in one place.It was further reported that the product was not available anymore.The patient did not require hospitalization and did not receive treatment for the content of the heat wrap leaked.No harm to the patient was caused, only her clothes and the flat were dirty.This only happened once.The action taken in response to the event of the product was unknown.The outcome of the event was unknown.Additional information received from product quality complaint (pqc) group included investigation results.Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass heat cells damaged/leaking.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Reasonably suggest device malfunction: yes.Severity of harm: s3.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following complaint intake, triage, and investigation (citi) customizable search was performed: scope: site notification date: 08/12/2016 through 08/012/2019/manufacturing site: pfizer albany/complaint class: product use.Attribute/ complaint sub class: heat cells damaged/leaking.The citi customizable search returned a total of 3 complaints for flexible use products during this time period for the class/subclass.None were confirmed to have a manufacturing process root cause for a complaint of heat cells damaged/leaking.The complaints were evaluated to identify any potential trend.The calculated complaints per million produced (cpmp) result of 32 complaints was above the upper control limit (ucl) of 14 complaints per sop-105746 "complaint trending guideline", effective 05 feb 2019.An evaluation of the 36 month trend chart did not show a significant increase over time.Exped trend actions taken: based on this citi customizable search, there is not a trend identified for the subclass of heat cells damaged/leaking for flexible use product, refer to attachment flexible use heat cells damaged leaking 08-12-2016 to 08-12-2019.There is no further action required.Follow-up (19aug2019 and 03sep2019): new information received from a contactable consumer includes patient age, device data (lot number and expiration date), deny of hospitalization, deny of treatment and event details.Follow-up (05nov2019): new information received from a contactable consumer includes: event data (onset date added).Follow-up attempts are completed.No further information is expected., comment: based on the available information, the patient reported that "one heat wrap had damaged heat cells where the content leaked/ little black crumbs on the floor".There was "no adverse event" such as burn 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 was assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No remedial action/corrective action/field safety corrective action is suggested at this time.
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Manufacturer Narrative
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Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass heat cells damaged/leaking.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Reasonably suggest device malfunction: yes.Severity of harm: s3.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following complaint intake, triage, and investigation (citi) customizable search was performed: scope: site notification date: 08/12/2016 through 08/012/2019/manufacturing site: pfizer albany/complaint class: product use.Attribute/ complaint sub class: heat cells damaged/leaking.The citi customizable search returned a total of 3 complaints for flexible use products during this time period for the class/subclass.None were confirmed to have a manufacturing process root cause for a complaint of heat cells damaged/leaking.The complaints were evaluated to identify any potential trend.The calculated complaints per million produced (cpmp) result of 32 complaints was above the upper control limit (ucl) of 14 complaints per sop-105746 "complaint trending guideline", effective 05 feb 2019.An evaluation of the 36 month trend chart did not show a significant increase over time.Exped trend actions taken: based on this citi customizable search, there is not a trend identified for the subclass of heat cells damaged/leaking for flexible use product, refer to attachment flexible use heat cells damaged leaking 08-12-2016 to 08-12-2019.There is no fur.
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Search Alerts/Recalls
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