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| Lot Number T65606 |
| Device Problems
Labelling, Instructions for Use or Training Problem (1318); Incomplete or Missing Packaging (2312); Device Markings/Labelling Problem (2911)
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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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A complaint intake triage and investigation (citi) / summary investigation reasonably suggest device malfunction and severity of harm=s3, s4, s5 or unknown.This notifies that the severity of harm has been selected by the manufacturing site as s3.Reasonably suggest device malfunction?: no.Severity of harm: n/a (discrepant information is being queried).Complaint class: labeling/carton/insert.Complaint sub-class: missing insert/outsert/leaflet.Sterile-product: no.No capa previously identified, and no full investigation required.Summary of investigation is as follows: batch t65606 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.There was no impact on regulatory, product quality, market /clinical, and stability.It was not process related, and final confirmation status was not confirmed.Conclusion: the root cause category is non assignable (complaint not confirmed as quality defect).A complaint of a missing insert cannot be confirmed once the carton is opened by consumer.Evaluation of retain sample shows insert present in carton.Instructions are provided in the language of the intended market.After a wrap is pouched the product moves into the cartoning section.Pouched wraps arrive at the indexing cart and are stacked according to the current production count size.The product then travels in the transport conveyor through the insert pick off where the insert is placed in a slot in line with each stack of pouches.There is an automated detection system to verify the presence of the insert at 100% and that the correct insert is being used (prior to being inserted into the carton).When each index bucket aligns with an opened carton the pusher feet move forward to slide the product and the insert into the carton.The pusher feet, following a cam then retract allowing the cartons to cont.
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Event Description
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Event verbatim [preferred term] there is no usage instruction inside [device issue] ,.Case narrative:the initial case was missing the following minimum criteria: no adverse event.Upon receipt of follow-up information on 04dec2019, 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 neck, shoulder & wrist) device lot number t65606, expiration date 31oct2020, from an unspecified date at an unspecified frequency for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient bought the packing (lot: t65606 11/16 and expiration date 31oct2020) today, and therese was no usage instruction inside."des there are instructions on the back, nur as the pack specifically refers to the missing ui i just wanted to know if there might be more to be careful with i.E.Not to use when pregnant".The action taken with thermacare heatwrap and outcome were unknown.The follow information provided by product quality complaint group: a complaint intake triage and investigation (citi) / summary investigation reasonably suggest device malfunction and severity of harm=s3, s4, s5 or unknown.This notifies that the severity of harm has been selected by the manufacturing site as s3.Reasonably suggest device malfunction?: no.Severity of harm: n/a (discrepant information is being queried).Complaint class: labeling/carton/insert.Complaint sub-class: missing insert/outsert/leaflet.Sterile-product: no.No capa previously identified, and no full investigation required.Summary of investigation is as follows: batch t65606 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.There was no impact on regulatory, product quality, market /clinical, and stability.It was not process related, and final confirmation status was not confirmed.Conclusion: the root cause category is non assignable (complaint not confirmed as quality defect).A complaint of a missing insert cannot be confirmed once the carton is opened by consumer.Evaluation of retain sample shows insert present in carton.Instructions are provided in the language of the intended market.After a wrap is pouched the product moves into the cartoning section.Pouched wraps arrive at the indexing cart and are stacked according to the current production count size.The product then travels in the transport conveyor through the insert pick off where the insert is placed in a slot in line with each stack of pouches.There is an automated detection system to verify the presence of the insert at 100% and that the correct insert is being used (prior to being inserted into the carton).When each index bucket aligns with an opened carton the pusher feet move forward to slide the product and the insert into the carton.The pusher feet, following a cam then retract allowing the cartons to continue transitioning down the line.Each end of the carton is then automatically glued and closed before it exits the cartoning machine.If an insert is missing, the cartoner will not glue on the operator side, then carton and pouches will be diverted off of the line.Each carton will then pass over a check weigher to ensure it has the appropriate quantity of pouched product for the particular batch.Due to normal variation in product weight the check weigher cannot be set to detect the absence of an insert, in the carton, thus the required 10 minute attribute check for the insert presence.Manufacturing quality data is captured by quality windows (qws), an electronic system that stores data from the manufacturing in process quality testing and downtime records.The qw's data for missing inserts is required every 10 minutes of cartoner uptime per standard operating procedure - packaging instructions procedure.Review of qws records indicated that there were no defects entered for the batch.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.Document review summary: batch t65606 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.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 inspections were performed and all inspection criteria was met.There were no pack attribute defects recorded for the batch.There were no pack attribute defects recorded for missing inserts.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch.Design related: no.Reserve sample evaluation required and description is as follows: the visual inspection of a retain sample included one carton and the three pouched wraps inside and shows no obvious defects.Insert is present in carton.Retain sample evaluation performed on 18apr2019 for an unrelated investigation.No reserve sample testing required.Reserve defect not confirmed.Missing insert outsert leaflet flex use search from 26nov2017 to 26nov2019.Actions taken: a trend does not exist for this lot.An evaluation of the complaint history confirms that this is the first complaint for the sub class missing insert/outsert/leaflet received at the manufacturing site requiring an evaluation for this lot.Per complaint trending guideline, a visual evaluation was performed to identify a potential trend.A trend was not identified.On the basis of this evaluation, a trend does not exist for this lot.No expedite trend were identified.Assessment & rationale: 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: date contacted: 26nov2017 through 26nov2019/manufacturing site/complaint class: labeling/carton/insert complaint subclass: missing insert/outsert/leaflet.The citi customizable search returned a total of 1 complaint for flexible use products during this time period for the class/subclass.The complaint is not confirmed to have a manufacturing process root cause for a complaint of missing insert/outsert/leaflet.The subclass does not show increase over a 24 month trend.Based on this citi customizable search, there is not a trend identified for the subclass of missing insert/outsert/leaflet.Refer to the attached 24 month trend chart attached missing insert outsert leaflet flex use (b)(6)2017 to (b)(6) 2019.Actions taken: based on this citi customizable search, there is not a trend identified for the subclass of missing insert/outsert/leaflet.There was no other trend identified.Sample availability was unknown and site sample status was not received.No follow-up attempts needed.No further information is expected.Company clinical evaluation comment: based on available information, the patient reported there is no usage instruction inside, which represents a potential device malfunction, is non-serious and medically 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 device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on available information, the patient reported there is no usage instruction inside, which represents a potential device malfunction, is non-serious and medically 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 device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time.
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Manufacturer Narrative
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A complaint intake triage and investigation (citi) / summary investigation reasonably suggest device malfunction and severity of harm=s3, s4, s5 or unknown.This notifies that the severity of harm has been selected by the manufacturing site as s3.Reasonably suggest device malfunction?: no.Severity of harm: n/a (discrepant information is being queried).Complaint class: labeling/carton/insert.Complaint sub-class: missing insert/outsert/leaflet.Sterile-product: no.No capa previously identified, and no full investigation required.Summary of investigation is as follows: batch t65606 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.There was no impact on regulatory, product quality, market /clinical, and stability.It was not process related, and final confirmation status was not confirmed.Conclusion: the root cause category is non assignable (complaint not confirmed as quality defect).A complaint of a missing insert cannot be confirmed once the carton is opened by consumer.Evaluation of retain sample shows insert present in carton.Instructions are provided in the language of the intended market.After a wrap is pouched the product moves into the cartoning section.Pouched wraps arrive at the indexing cart and are stacked according to the current production count size.The product then travels in the transport conveyor through the insert pick off where the insert is placed in a slot in line with each stack of pouches.There is an automated detection system to verify the presence of the insert at 100% and that the correct insert is being used (prior to being inserted into the carton).When each index bucket aligns with an opened carton the pusher feet move forward to slide the product and the insert into the carton.The pusher feet, following a cam then retract allowing the cartons to continue transitioning down the line.Each end of the carton is then automatically glued and closed before it exits the cartoning machine.If an insert is missing, the cartoner will not glue on the operator side, then carton and pouches will be diverted off of the line.Each carton will then pass over a check weigher to ensure it has the appropriate quantity of pouched product for the particular batch.Due to normal variation in product weight the check weigher cannot be set to detect the absence of an insert, in the carton, thus the required 10 minute attribute check for the insert presence.Manufacturing quality data is captured by quality windows (qws), an electronic system that stores data from the manufacturing in process quality testing and downtime records.The qw's data for missing inserts is required every 10 minutes of cartoner uptime per standard operating procedure - packaging instructions procedure.Review of qws records indicated that there were no defects entered for the batch.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.Document review summary: batch t65606 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.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 inspections were performed and all inspection criteria was met.There were no pack attribute defects recorded for the batch.There were no pack attribute defects recorded for missing inserts.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch.Design related: no.Reserve sample evaluation required and description is as follows: the visual inspection of a retain sample included one carton and the three pouched wraps inside and shows no obvious defects.Insert is present in carton.Retain sample evaluation performed on 18apr2019 for an unrelated investigation.No reserve sample testing required.Reserve defect not confirmed.Missing insert outsert leaflet flex use search from 26nov2017 to 26nov2019.Actions taken: a trend does not exist for this lot.An evaluation of the complaint history confirms that this is the first complaint for the sub class missing insert/outsert/leaflet received at the manufacturing site requiring an evaluation for this lot.Per complaint trending guideline, a visual evaluation was performed to identify a potential trend.A trend was not identified.On the basis of this evaluation, a trend does not exist for this lot.No expedite trend were identified.Exped trend assmt.& rationale: 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: date contacted: 11/26/2016 through 11/126/2019/manufacturing site: pfizer albany/complaint class: labeling/carton/insert complaint subclass: missing insert/outsert/leaflet the citi customizable search returned a total of 1 complaint for flexible use products during this time period for the class/subclass.The complaint is not confirmed to have a manufacturing process root cause for a complaint of missing insert/outsert/leaflet.The subclass does not show increase over a 36 month trend.Exped trend actions taken: based on this citi customizable search, there is not a trend identified for the subclass of missing insert/outsert/leaflet.Refer to the attached 36 month trend chart attached flex missing insert outsert leaflet 26-nov-2016 to 26-nov-2019 this investigation was reopened to change information in the lot trend assessment & rationale and expedite trend assessment & rationale sections.This change was due to a deviation found from sop-105746, complaint trending guidelines, effective dates 19-nov-2019 and 24-feb-2020.A notification of nonconformance was opened (b)(4).This deviation will not change the conclusion of the investigation.Sample availability was unknown and site sample status was not received.
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Event Description
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Event verbatim [preferred term], there is no usage instruction inside [device issue], , narrative: the initial case was missing the following minimum criteria: no adverse event.Upon receipt of follow-up information on 04dec2019, 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 neck, shoulder & wrist) device lot number t65606, expiration date 31oct2020, from an unspecified date at an unspecified frequency for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient bought the packing (lot: t65606 11/16 and expiration date 31oct2020) today, and therese was no usage instruction inside."des there are instructions on the back, nur as the pack specifically refers to the missing ui i just wanted to know if there might be more to be careful with i.E.Not to use when pregnant".The action taken with thermacare heatwrap and outcome were unknown.The follow information provided by product quality complaint group: a complaint intake triage and investigation (citi) / summary investigation reasonably suggest device malfunction and severity of harm=s3, s4, s5 or unknown.This notifies that the severity of harm has been selected by the manufacturing site as s3.Reasonably suggest device malfunction?: no.Severity of harm: n/a (discrepant information is being queried).Complaint class: labeling/carton/insert.Complaint sub-class: missing insert/outsert/leaflet.Sterile-product: no.No capa previously identified, and no full investigation required.Summary of investigation is as follows: batch t65606 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.There was no impact on regulatory, product quality, market /clinical, and stability.It was not process related, and final confirmation status was not confirmed.Conclusion: the root cause category is non assignable (complaint not confirmed as quality defect).A complaint of a missing insert cannot be confirmed once the carton is opened by consumer.Evaluation of retain sample shows insert present in carton.Instructions are provided in the language of the intended market.After a wrap is pouched the product moves into the cartoning section.Pouched wraps arrive at the indexing cart and are stacked according to the current production count size.The product then travels in the transport conveyor through the insert pick off where the insert is placed in a slot in line with each stack of pouches.There is an automated detection system to verify the presence of the insert at 100% and that the correct insert is being used (prior to being inserted into the carton).When each index bucket aligns with an opened carton the pusher feet move forward to slide the product and the insert into the carton.The pusher feet, following a cam then retract allowing the cartons to continue transitioning down the line.Each end of the carton is then automatically glued and closed before it exits the cartoning machine.If an insert is missing, the cartoner will not glue on the operator side, then carton and pouches will be diverted off of the line.Each carton will then pass over a check weigher to ensure it has the appropriate quantity of pouched product for the particular batch.Due to normal variation in product weight the check weigher cannot be set to detect the absence of an insert, in the carton, thus the required 10 minute attribute check for the insert presence.Manufacturing quality data is captured by quality windows (qws), an electronic system that stores data from the manufacturing in process quality testing and downtime records.The qw's data for missing inserts is required every 10 minutes of cartoner uptime per standard operating procedure - packaging instructions procedure.Review of qws records indicated that there were no defects entered for the batch.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.Document review summary: batch t65606 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.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 inspections were performed and all inspection criteria was met.There were no pack attribute defects recorded for the batch.There were no pack attribute defects recorded for missing inserts.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch.Design related: no.Reserve sample evaluation required and description is as follows: the visual inspection of a retain sample included one carton and the three pouched wraps inside and shows no obvious defects.Insert is present in carton.Retain sample evaluation performed on 18apr2019 for an unrelated investigation.No reserve sample testing required.Reserve defect not confirmed.Missing insert outsert leaflet flex use search from 26nov2017 to 26nov2019.Actions taken: a trend does not exist for this lot.An evaluation of the complaint history confirms that this is the first complaint for the sub class missing insert/outsert/leaflet received at the manufacturing site requiring an evaluation for this lot.Per complaint trending guideline, a visual evaluation was performed to identify a potential trend.A trend was not identified.On the basis of this evaluation, a trend does not exist for this lot.No expedite trend were identified.Exped trend assmt.& rationale: 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: date contacted: 11/26/2016 through 11/126/2019/manufacturing site: pfizer albany/complaint class: labeling/carton/insert complaint subclass: missing insert/outsert/leaflet the citi customizable search returned a total of 1 complaint for flexible use products during this time period for the class/subclass.The complaint is not confirmed to have a manufacturing process root cause for a complaint of missing insert/outsert/leaflet.The subclass does not show increase over a 36 month trend.Exped trend actions taken: based on this citi customizable search, there is not a trend identified for the subclass of missing insert/outsert/leaflet.Refer to the attached 36 month trend chart attached flex missing insert outsert leaflet 26-nov-2016 to 26-nov-2019 this investigation was reopened to change information in the lot trend assessment & rationale and expedite trend assessment & rationale sections.This change was due to a deviation found from sop-105746, complaint trending guidelines, effective dates 19-nov-2019 and 24-feb-2020.A notification of nonconformance was opened (b)(4).This deviation will not change the conclusion of the investigation.Sample availability was unknown and site sample status was not received.No follow-up attempts needed.No further information is expected.Follow-up (12feb2020): follow-up attempts are completed.No further information is expected.Follow-up (08oct2020): new information received from a product quality complaints group included: updated expedite trends.Follow-up attempts are completed.No further information is expected., comment: based on available information, the patient reported there is no usage instruction inside, which represents a potential device malfunction, is non-serious and medically 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 device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time.
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Search Alerts/Recalls
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