|
|
| Lot Number S68525 |
| Device Problem
Unintended Ejection (1234)
|
| Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
|
Event Type
malfunction
|
|
Manufacturer Narrative
|
|
The visual inspection of a retain sample included one carton and the three pouched wraps inside and shows no obvious defects.Form-46455 retain sample inspection form documented the retain evaluation performed on 19-apr-2018 for an unrelated complaint.An evaluation of the complaint history confirms that this is the third complaint for the sub class wet/damp for this batch.Two previous complaints were not confirmed to have a manufacturing related root cause for the complaint.On the basis of this evaluation, a trend does not exist for this batch.Review of the batch device history record for this batch concludes all release requirements were met.Review of the packaging attributes (pouch, carton, and shipper container) quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria was met.A total of 6240 pti (pouch leak) tests were performed with 14 failures.Pouch leak maximum acceptance limit for a sample size of 6225 pti tests is 114 failures per pouch leak test sampling plan extension cd-40761, effective date: 06-mar-2017.There were no pack attribute defects recorded the batch.Shiftly transition production notes were reviewed.There were issues with bad long seals, pin holes, seal scope faults and wraps turned wrong causing product in the end seal.Adjustments were made to the product placement throughout the run alone with process cleaning the cross seal, anvil, sonotrode and knife to correct pouch leaks.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch that would cause a wet/damp wrap complaint.Batch s68525 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The root cause category is non assignable (complaint not confirmed).Sample is not available for evaluation by the site.Once a pouch is open a pouch leak can not be confirmed.In general - as.
|
| |
|
Event Description
|
|
Event verbatim [preferred term] one hours after use the customer noticed fluid from the heatwrap [device leakage] ,.Case narrative: this is a spontaneous report from a contactable pharmacist.A male patient of unknown age started to receive thermacare heatwrap (thermacare fuer flexible anwendung) lot: s68525, expiry date: apr2020, via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for an unspecified indication.Medical history and concomitant medications were not reported.One hour after use the patient noticed fluid from the heatwrap.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.The visual inspection of a retain sample included one carton and the three pouched wraps inside and shows no obvious defects.Form-46455 retain sample inspection form documented the retain evaluation performed on 19-apr-2018 for an unrelated complaint.An evaluation of the complaint history confirms that this is the third complaint for the sub class wet/damp for this batch.Two previous complaints were not confirmed to have a manufacturing related root cause for the complaint.On the basis of this evaluation, a trend does not exist for this batch.Review of the batch device history record for this batch concludes all release requirements were met.Review of the packaging attributes (pouch, carton, and shipper container) quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria was met.A total of 6240 pti (pouch leak) tests were performed with 14 failures.Pouch leak maximum acceptance limit for a sample size of 6225 pti tests is 114 failures per pouch leak test sampling plan extension cd-40761, effective date: 06-mar-2017.There were no pack attribute defects recorded the batch.Shiftly transition production notes were reviewed.There were issues with bad long seals, pin holes, seal scope faults and wraps turned wrong causing product in the end seal.Adjustments were made to the product placement throughout the run alone with process cleaning the cross seal, anvil, sonotrode and knife to correct pouch leaks.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch that would cause a wet/damp wrap complaint.Batch s68525 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The root cause category is non assignable (complaint not confirmed).Sample is not available for evaluation by the site.Once a pouch is open a pouch leak can not be confirmed.In general - as wraps heat-up and cool, condensation (moisture/water droplets) are generated.A pouch leak can cause the wrap to prematurely heat up inside the wrapper, which subsequently cools, and produces condensation inside the pouch which was noted by the consumer.The pti data was reviewed and there were no leak results outside the required specifications per flexible use spec-22609, effective date: 01mar2017.Our manufacturing operations employ quality control procedures which include in process testing, and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.Pouch leaks are considered a major attribute.Testing is performed on four pouched wraps every ten minutes of flow wrapper uptime (per spec-22609; effective date: 01-mar-2017) to minimize the occurrence of defective pouches in the batch.Maximum acceptable pouch leak fails are based on the number of the performed sample tests.An experimental order (e/o) to test a new anvil on the flow wrapper was conducted under (b)(4) and it was concluded that the anvil was fit for its intended use.An occurrence ((b)(4)) was created to track the implementation of the new anvil with two hermetic sealing lines for both m and b lines.Individual child records will monitor the implementation of the change control for each line.After a review of the leak data the batch in question did not have any leak results outside the release specifications.Pouch sealing defects are being trended for all batches at the site level with every complaint (by batch) using the lot history report attached to the complaint in pcom by complaint intake and by the data and analysis group monthly.No additional action will be taken for pouch leak defects related to this batch.Corrective actions are already identified to correct the defect.The product quality for the batch is not impacted by this complaint.Based on satisfactory documentation reviewed, considering that no issue was found in the manufacturing and packaging process, all checks during in-process control were conforming, that no other complaint was received on this lot, it is possible to assume that the origin of the defect notified is not attributable to activities performed during the manufacturing and packaging operations at aprilia plant.Follow-up (09aug2018): this follow-up report is being submitted to upgrade this case to a reportable mdr.Company clinical evaluation comment the event "noticed fluid from the heatrap" (device leakage) was assessed as non-serious.No other 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 was assessed as associated with the use of the device., comment: the event "noticed fluid from the heatrap" (device leakage) was assessed as non-serious.No other 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 was assessed as associated with the use of the device.
|
| |
|
Event Description
|
|
Event verbatim [preferred term] one hours after use the customer noticed fluid from the heatwrap [device leakage] ,.Case narrative:this is a spontaneous report from a contactable pharmacist.A male patient of unknown age started to receive thermacare heatwrap (thermacare fuer flexible anwendung) lot: s68525, expiry date: apr2020, via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for an unspecified indication.Medical history and concomitant medications were not reported.One hour after use the patient noticed fluid from the heatwrap.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.The visual inspection of a retain sample included one carton and the three pouched wraps inside and shows no obvious defects.Form-46455 retain sample inspection form documented the retain evaluation performed on 19-apr-2018 for an unrelated complaint.An evaluation of the complaint history confirms that this is the third complaint for the sub class wet/damp for this batch.Two previous complaints were not confirmed to have a manufacturing related root cause for the complaint.On the basis of this evaluation, a trend does not exist for this batch.Review of the batch device history record for this batch concludes all release requirements were met.Review of the packaging attributes (pouch, carton, and shipper container) quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria was met.A total of 6240 pti (pouch leak) tests were performed with 14 failures.Pouch leak maximum acceptance limit for a sample size of 6225 pti tests is 114 failures per pouch leak test sampling plan extension cd-40761, effective date: 06-mar-2017.There were no pack attribute defects recorded the batch.Shiftly transition production notes were reviewed.There were issues with bad long seals, pin holes, seal scope faults and wraps turned wrong causing product in the end seal.Adjustments were made to the product placement throughout the run alone with process cleaning the cross seal, anvil, sonotrode and knife to correct pouch leaks.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch that would cause a wet/damp wrap complaint.Batch s68525 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The root cause category is non assignable (complaint not confirmed).Sample is not available for evaluation by the site.Once a pouch is open a pouch leak can not be confirmed.In general - as wraps heat-up and cool, condensation (moisture/water droplets) are generated.A pouch leak can cause the wrap to prematurely heat up inside the wrapper, which subsequently cools, and produces condensation inside the pouch which was noted by the consumer.The pti data was reviewed and there were no leak results outside the required specifications per flexible use spec-22609, effective date: 01mar2017.Our manufacturing operations employ quality control procedures which include in process testing, and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.Pouch leaks are considered a major attribute.Testing is performed on four pouched wraps every ten minutes of flow wrapper uptime (per spec-22609; effective date: 01-mar-2017) to minimize the occurrence of defective pouches in the batch.Maximum acceptable pouch leak fails are based on the number of the performed sample tests.An experimental order (e/o) to test a new anvil on the flow wrapper was conducted under pr-2134579 and it was concluded that the anvil was fit for its intended use.An occurrence (pr-2224263) was created to track the implementation of the new anvil with two hermetic sealing lines for both m and b lines.Individual child records will monitor the implementation of the change control for each line.After a review of the leak data the batch in question did not have any leak results outside the release specifications.Pouch sealing defects are being trended for all batches at the site level with every complaint (by batch) using the lot history report attached to the complaint in pcom by complaint intake and by the data and analysis group monthly.No additional action will be taken for pouch leak defects related to this batch.Corrective actions are already identified to correct the defect.The product quality for the batch is not impacted by this complaint.Based on satisfactory documentation reviewed, considering that no issue was found in the manufacturing and packaging process, all checks during in-process control were conforming, that no other complaint was received on this lot, it is possible to assume that the origin of the defect notified is not attributable to activities performed during the manufacturing and packaging operations at aprilia plant.Additional information has been requested and will be provided as it becomes available.Follow-up (09aug2018): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (24dec2019): this follow-up is being submitted to notify that an investigation of the device is ongoing.Company clinical evaluation comment the event "noticed fluid from the heatrap" (device leakage) was assessed as non-serious.No other 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 was assessed as associated with the use of the device., comment: the event "noticed fluid from the heatrap" (device leakage) was assessed as non-serious.No other 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 was assessed as associated with the use of the device.
|
| |
|
Manufacturer Narrative
|
|
The visual inspection of a retain sample included one carton and the three pouched wraps inside and shows no obvious defects.Form-46455 retain sample inspection form documented the retain evaluation performed on 19-apr-2018 for an unrelated complaint.An evaluation of the complaint history confirms that this is the third complaint for the sub class wet/damp for this batch.Two previous complaints were not confirmed to have a manufacturing related root cause for the complaint.On the basis of this evaluation, a trend does not exist for this batch.Review of the batch device history record for this batch concludes all release requirements were met.Review of the packaging attributes (pouch, carton, and shipper container) quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria was met.A total of 6240 pti (pouch leak) tests were performed with 14 failures.Pouch leak maximum acceptance limit for a sample size of 6225 pti tests is 114 failures per pouch leak test sampling plan extension cd-40761, effective date: 06-mar-2017.There were no pack attribute defects recorded the batch.Shiftly transition production notes were reviewed.There were issues with bad long seals, pin holes, seal scope faults and wraps turned wrong causing product in the end seal.Adjustments were made to the product placement throughout the run alone with process cleaning the cross seal, anvil, sonotrode and knife to correct pouch leaks.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch that would cause a wet/damp wrap complaint.Batch s68525 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The root cause category is non assignable (complaint not confirmed).Sample is not available for evaluation by the site.Once a pouch is open a pouch leak can not be confirmed.In general - as.
|
| |
|
Manufacturer Narrative
|
|
The visual inspection of a retain sample included one carton and the three pouched wraps inside and shows no obvious defects.Form-46455 retain sample inspection form documented the retain evaluation performed on 19-apr-2018 for an unrelated complaint.An evaluation of the complaint history confirms that this is the third complaint for the sub class wet/damp for this batch.Two previous complaints were not confirmed to have a manufacturing related root cause for the complaint.On the basis of this evaluation, a trend does not exist for this batch.Review of the batch device history record for this batch concludes all release requirements were met.Review of the packaging attributes (pouch, carton, and shipper container) quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria was met.A total of 6240 pti (pouch leak) tests were performed with 14 failures.Pouch leak maximum acceptance limit for a sample size of 6225 pti tests is 114 failures per pouch leak test sampling plan extension cd-40761, effective date: 06-mar-2017.There were no pack attribute defects recorded the batch.Shiftly transition production notes were reviewed.There were issues with bad long seals, pin holes, seal scope faults and wraps turned wrong causing product in the end seal.Adjustments were made to the product placement throughout the run alone with process cleaning the cross seal, anvil, sonotrode and knife to correct pouch leaks.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch that would cause a wet/damp wrap complaint.Batch s68525 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The root cause category is non assignable (complaint not confirmed).Sample is not available for evaluation by the site.Once a pouch is open a pouch leak can not be confirmed.In general - as.
|
| |
|
Event Description
|
|
Event verbatim [preferred term] one hours after use the customer noticed fluid from the heatwrap [device leakage] ,.Case narrative:this is a spontaneous report from a contactable pharmacist.A male patient of unknown age started to receive thermacare heatwrap (thermacare fuer flexible anwendung) lot: s68525, expiry date: apr2020, via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for an unspecified indication.Medical history and concomitant medications were not reported.One hour after use the patient noticed fluid from the heatwrap.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.The visual inspection of a retain sample included one carton and the three pouched wraps inside and shows no obvious defects.Form-46455 retain sample inspection form documented the retain evaluation performed on 19-apr-2018 for an unrelated complaint.An evaluation of the complaint history confirms that this is the third complaint for the sub class wet/damp for this batch.Two previous complaints were not confirmed to have a manufacturing related root cause for the complaint.On the basis of this evaluation, a trend does not exist for this batch.Review of the batch device history record for this batch concludes all release requirements were met.Review of the packaging attributes (pouch, carton, and shipper container) quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria was met.A total of 6240 pti (pouch leak) tests were performed with 14 failures.Pouch leak maximum acceptance limit for a sample size of 6225 pti tests is 114 failures per pouch leak test sampling plan extension cd-40761, effective date: 06-mar-2017.There were no pack attribute defects recorded the batch.Shiftly transition production notes were reviewed.There were issues with bad long seals, pin holes, seal scope faults and wraps turned wrong causing product in the end seal.Adjustments were made to the product placement throughout the run alone with process cleaning the cross seal, anvil, sonotrode and knife to correct pouch leaks.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch that would cause a wet/damp wrap complaint.Batch s68525 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The root cause category is non assignable (complaint not confirmed).Sample is not available for evaluation by the site.Once a pouch is open a pouch leak can not be confirmed.In general - as wraps heat-up and cool, condensation (moisture/water droplets) are generated.A pouch leak can cause the wrap to prematurely heat up inside the wrapper, which subsequently cools, and produces condensation inside the pouch which was noted by the consumer.The pti data was reviewed and there were no leak results outside the required specifications per flexible use spec-22609, effective date: 01mar2017.Our manufacturing operations employ quality control procedures which include in process testing, and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.Pouch leaks are considered a major attribute.Testing is performed on four pouched wraps every ten minutes of flow wrapper uptime (per spec-22609; effective date: 01-mar-2017) to minimize the occurrence of defective pouches in the batch.Maximum acceptable pouch leak fails are based on the number of the performed sample tests.An experimental order (e/o) to test a new anvil on the flow wrapper was conducted under pr-2134579 and it was concluded that the anvil was fit for its intended use.An occurrence (pr-2224263) was created to track the implementation of the new anvil with two hermetic sealing lines for both m and b lines.Individual child records will monitor the implementation of the change control for each line.After a review of the leak data the batch in question did not have any leak results outside the release specifications.Pouch sealing defects are being trended for all batches at the site level with every complaint (by batch) using the lot history report attached to the complaint in pcom by complaint intake and by the data and analysis group monthly.No additional action will be taken for pouch leak defects related to this batch.Corrective actions are already identified to correct the defect.The product quality for the batch is not impacted by this complaint.Based on satisfactory documentation reviewed, considering that no issue was found in the manufacturing and packaging process, all checks during in-process control were conforming, that no other complaint was received on this lot, it is possible to assume that the origin of the defect notified is not attributable to activities performed during the manufacturing and packaging operations at the plant.Follow-up (09aug2018): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (24dec2019): this follow-up is being submitted to notify that an investigation of the device is ongoing.Follow-up (24feb2020): this follow-up is being submitted to notify that the investigation is closed; no further results are expected., comment: the event "noticed fluid from the heatrap" (device leakage) was assessed as non-serious.No other 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 was assessed as associated with the use of the device.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.The root cause category is non-assignable (complaint not confirmed).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.
|
| |
|
Search Alerts/Recalls
|
|
|
