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| Device Problem
Break (1069)
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| Patient Problem
Laceration(s) (1946)
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Event Type
malfunction
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Manufacturer Narrative
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The severity of harm has been selected by the manufacturing site as s3.Reasonably suggest device malfunction: yes.Samples available: unknown.Sample status: sample availability unknown.Photos available: no.
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Event Description
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Event verbatim [preferred term] part of the syringe broke which resulting in the surgical scrub technician getting a minor cut.[device issue], part of the syringe broke which resulting in the surgical scrub technician getting a minor cut.[wound], part of the syringe broke which resulting in the surgical scrub technician getting a minor cut.[occupational exposure to product].Case narrative: this is a spontaneous report from a contactable nurse via pfizer sales representative.A patient of unspecified age and gender started to receive absorbable gelatin (gel-flow nt), via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient was a surgical tech who was mixing the gel flow product preparing for a case where it was to be used and during the mixing process, part of the syringe broke which resulting in the surgical scrub technician getting a minor cut.This incident was more so about the technician involved in mixing it, not the patient who would use the absorbable gelatin.No event took place after use of the product.The action taken in response to the events for absorbable gelatin and outcome for events was unknown.On 24oct2019, the product quality complaints department reported that the severity of harm has been selected by the manufacturing site as s3.Reasonably suggest device malfunction: yes.Samples available: unknown.Sample status: sample availability unknown.Photos available: no.Follow-up (23aug2019): follow-up attempts are completed.No further information is expected.Follow-up (24oct2019): new information reported from the product quality complaints department includes: the investigation report where the severity of harm was considered s3 and device malfunction: yes.Company clinical evaluation comment: the reported event "syringe broke resulting technician getting a minor cut" was nonserious, and did not cause serious injury to the user, a surgical tech who was mixing the gel flow product preparing for a case where it was to be used and during the mixing process.This is a single potential device malfunction which has a theoretical risk to cause serious injury to user, if it were to recur.The company conducted an investigation, and final investigation result has not received.Follow-up attempts are completed.No further information is expected.Comment: the reported event "syringe broke resulting technician getting a minor cut" was nonserious, and did not cause serious injury to the user, a surgical tech who was mixing the gel flow product preparing for a case where it was to be used and during the mixing process.This is a single potential device malfunction which has a theoretical risk to cause serious injury to user, if it were to recur.The company conducted an investigation, and final investigation result has not received.
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Manufacturer Narrative
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On 29oct2019, manufacturing record review summary: reviewed 114 lots manufactured in the past 12 months and did not identify any anomalies.An nce would have been generated to address any product that was out of spec per ip10-0899.There were no nces initiated that may have led to the initial complaint.Complaint history: a rate of (b)(4) is below this occurrence rate and therefore does not appear that a trend exists.Investigation summary: reviewed gel-flow nt nce and none would have been likely associated with the cause of the issue.1) nces were reviewed for any possible equipment failure that may have contributed to this issue and none were identified.2) nces were reviewed at the component level for the syringe component and no supplier non-conformances were identified.Probable cause: based off this information the cause of this issue is undetermined at this time and there is no internal requirement identified that was not met.On 24oct2019, the severity of harm has been selected by the manufacturing site as s3.Reasonably suggest device malfunction: yes.Samples available: unknown.Sample status: sample availability unknown.Photos available: no.
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Event Description
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Event verbatim [preferred term] part of the syringe broke which resulting in the surgical scrub technician getting a minor cut.[device issue] , part of the syringe broke which resulting in the surgical scrub technician getting a minor cut.[wound] , part of the syringe broke which resulting in the surgical scrub technician getting a minor cut.[occupational exposure to product].Case narrative:this is a spontaneous report from a contactable nurse via pfizer sales representative.A patient of unspecified age and gender started to receive absorbable gelatin (gel-flow nt), via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient was a surgical tech who was mixing the gel flow product preparing for a case where it was to be used and during the mixing process, part of the syringe broke which resulting in the surgical scrub technician getting a minor cut.This incident was more so about the technician involved in mixing it, not the patient who would use the absorbable gelatin.No event took place after use of the product.The action taken in response to the events for absorbable gelatin and outcome for events was unknown.On 24oct2019, the product quality complaints department reported that the severity of harm has been selected by the manufacturing site as s3.Reasonably suggest device malfunction: yes.Samples available: unknown.Sample status: sample availability unknown.Photos available: no.On 29oct2019, information received from pqc site.Manufacturing record review summary: reviewed 114 lots manufactured in the past 12 months and did not identify any anomalies.An nce would have been generated to address any product that was out of spec per ip10-0899.There were no nces initiated that may have led to the initial complaint.Complaint history: a rate of 0.002% is below this occurrence rate and therefore does not appear that a trend exists.Investigation summary: reviewed gel-flow nt nce and none would have been likely associated with the cause of the issue.1) nces were reviewed for any possible equipment failure that may have contributed to this issue and none were identified.2) nces were reviewed at the component level for the syringe component and no supplier non-conformances were identified.Probable cause: based off this information the cause of this issue is undetermined at this time and there is no internal requirement identified that was not met.Follow-up (23aug2019): follow-up attempts are completed.No further information is expected.Follow-up (24oct2019): new information reported from the product quality complaints department includes: the investigation report where the severity of harm was considered s3 and device malfunction: yes.Follow-up attempts are completed.No further information is expected.Follow-up (29oct2019): new information received from product quality complaint group included: investigation report.Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment: the reported event "part of the syringe broke which resulting in the surgical scrub technician getting a minor cut" was non-serious, and did not cause serious injury to the user, a surgical tech who was mixing the gel flow product preparing for a case where it was to be used and during the mixing process.This is a single potential device malfunction which has a theoretical risk to cause serious injury to user, if it were to recur.The company conducted an investigation, and final investigation result has not received.The follow-up information received does not alter the previous company clinical evaluation., comment: the reported event "part of the syringe broke which resulting in the surgical scrub technician getting a minor cut" was non-serious, and did not cause serious injury to the user, a surgical tech who was mixing the gel flow product preparing for a case where it was to be used and during the mixing process.This is a single potential device malfunction which has a theoretical risk to cause serious injury to user, if it were to recur.The company conducted an investigation, and final investigation result has not received.The follow-up information received does not alter the previous company clinical evaluation.
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Event Description
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Event verbatim [preferred term] part of the syringe broke which resulting in the surgical scrub technician getting a minor cut.[device issue], part of the syringe broke which resulting in the surgical scrub technician getting a minor cut.[wound], part of the syringe broke which resulting in the surgical scrub technician getting a minor cut.[occupational exposure to product].Case narrative:this is a spontaneous report from a contactable nurse via pfizer sales representative.A patient of unspecified age and gender started to receive absorbable gelatin (gel-flow nt), via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient was a surgical tech who was mixing the gel flow product preparing for a case where it was to be used and during the mixing process, part of the syringe broke which resulting in the surgical scrub technician getting a minor cut.This incident was more so about the technician involved in mixing it, not the patient who would use the absorbable gelatin.No event took place after use of the product.The action taken in response to the events for absorbable gelatin and outcome for events was unknown.On 24oct2019, the product quality complaints department reported that the severity of harm has been selected by the manufacturing site as s3.Reasonably suggest device malfunction: yes.Samples available: unknown.Sample status: sample availability unknown.Photos available: no.On 29oct2019, information received from pqc site.Manufacturing record review summary: reviewed 114 lots manufactured in the past 12 months and did not identify any anomalies.An nce would have been generated to address any product that was out of spec per ip10-0899.There were no nces initiated that may have led to the initial complaint.Complaint history: a rate of (b)(4) is below this occurrence rate and therefore does not appear that a trend exists.Investigation summary: reviewed gel-flow nt nce and none would have been likely associated with the cause of the issue.1) nces were reviewed for any possible equipment failure that may have contributed to this issue and none were identified.2) nces were reviewed at the component level for the syringe component and no supplier non-conformances were identified.Probable cause: based off this information the cause of this issue is undetermined at this time and there is no internal requirement identified that was not met.On the date of 12dec2019, severity of harm: s2; qa review & rationale: based on the complaint narrative, the patient sustained a cut while mixing the product as the syringe broke during use.Review of complaint description concludes there is a device malfunction.Investigation findings: summary of investigation: based on the complaint narrative, the patient sustained a cut while mixing the product as the syringe broke during use.Review of complaint description concludes there is a device malfunction.Common cause root cause is always present to some degree in the process.Special cause root cause is something different happening at a certain time or place in the process.The hazard analysis list (hal) was reviewed to confirm that this issue described in this complaint is captured.The most related hazard/harm is: hazard id: h01-03, specifically: hazard number: sharp edges on the molded components; hazardous situation: user is exposed to sharp edges; harm: minor lacerations or injury.Therefore, no new hazard/harm has been identified and thus no updates to the hal or other parts of the risk file are required.Severity aligns with a severity of s2.Complaint conclusion (unconfirmed/confirmed/justified) & rationale: unconfirmed -preliminary investigation has not identified any manufacturing or process anomalies or deficiencies.Rationale: no nces and change orders were discovered which could have caused this issue.The dfmeca was reviewed and no design issues or deficiencies were identified which could have caused the issue.Site did not receive the sample.Follow-up (23aug2019): follow-up attempts are completed.No further information is expected.Follow-up (24oct2019): new information reported from the product quality complaints department includes: the investigation report where the severity of harm was considered s3 and device malfunction: yes.Follow-up attempts are completed.No further information is expected.Follow-up (29oct2019): new information received from product quality complaint group included: investigation report.Follow-up attempts are completed.No further information is expected.Follow-up (12dec2019): new information received from product quality complaint group included: investigation report.Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment:
the reported event "part of the syringe broke which resulting in the surgical scrub technician getting a minor cut" was non-serious, and did not cause serious injury to the user, a surgical tech who was mixing the gel flow product preparing for a case where it was to be used and during the mixing process.This is a single potential device malfunction which has a theoretical risk to cause serious injury to user, if it were to recur.The company conducted an investigation, and the cause of this issue is undetermined at this time and there is no internal requirement identified that was not met., comment: the reported event "part of the syringe broke which resulting in the surgical scrub technician getting a minor cut" was non-serious, and did not cause serious injury to the user, a surgical tech who was mixing the gel flow product preparing for a case where it was to be used and during the mixing process.This is a single potential device malfunction which has a theoretical risk to cause serious injury to user, if it were to recur.The company conducted an investigation, and the cause of this issue is undetermined at this time and there is no internal requirement identified that was not met.
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Manufacturer Narrative
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On 29oct2019, manufacturing record review summary: reviewed 114 lots manufactured in the past 12 months and did not identify any anomalies.An nce would have been generated to address any product that was out of spec per ip10-0899.There were no nces initiated that may have led to the initial complaint.Complaint history: a rate of 0.002% is below this occurrence rate and therefore does not appear that a trend exists.Investigation summary: reviewed gel-flow nt nce and none would have been likely associated with the cause of the issue.Nces were reviewed for any possible equipment failure that may have contributed to this issue and none were identified.Nces were reviewed at the component level for the syringe component and no supplier non-conformances were identified.Probable cause: based off this information the cause of this issue is undetermined at this time and there is no internal requirement identified that was not met.On (b)(6) 2019, the severity of harm has been selected by the manufacturing site as s3.Reasonably suggest device malfunction: yes.Samples available: unknown.Sample status: sample availability unknown.Photos available: no.On the date of (b)(6) 2019, severity of harm: s2; qa review & rationale: based on the complaint narrative, the patient sustained a cut while mixing the product as the syringe broke during use.Review of complaint description concludes there is a device malfunction.Investigation findings: summary of investigation: based on the complaint narrative, the patient sustained a cut while mixing the product as the syringe broke during use.Review of complaint description concludes there is a device malfunction.Common cause root cause is always present to some degree in the process.Special cause root cause is something different happening at a certain time or place in the process.The hazard analysis list (hal) was reviewed to confirm that this issue described in this complaint is captured.The most related hazard/harm is.
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Search Alerts/Recalls
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