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| Device Problems
Break (1069); Product Quality Problem (1506); Use of Device Problem (1670)
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| Patient Problems
Laceration(s) (1946); Pain (1994); Skin Discoloration (2074)
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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.Summary of investigation and conclusion: based on the complaint narrative, the patient sustained a cut/skin tear that caused pain while mixing the product as the syringe wing broke off.The patient applied band aid to the wound.Proper techniques of mixing were demonstrated.Review of complaint description concludes there is a device malfunction.
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Event Description
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Event verbatim [preferred term] difficult to her [device difficult to use] , strain to her palm, leaving marks and resulted in some unwanted pain [pain in extremity], strain to her palm, leaving marks and resulted in some unwanted pain [muscle strain], skin tear [skin laceration].Case narrative: this is a spontaneous report from a contactable nurse via pfizer sales representative.A nurse reported that she had difficulties mixing the absorbable gelatin (gel-flow nt) syringe product.She explained that mixing the syringe a certain way caused strain to her palm because the flat /bottom part of the purple syringe would press firmly into her palms leaving marks, on an unspecified date.She said it was difficult for her; and resulted in some unwanted pain.As further reported on 22aug2019, the nurse informed that no patient was involved.Injury was to a staff person who was mixing the gelflow.The difficulty in mixing the gel-flow (the extreme resistance of the substance), caused the syringe wing to break off resulting in a skin tear of the staff person.It was reported that the event did not take place after the use of the product, and the nurse was provided with alternative mixing techniques to avoid pain.On 28aug2019, the nurse clarified that she was not the staff person mixing the gel-flow nt and stated no one was injured.The nurse stated that it was a female certified scrub tech that mixed the gel-flow nt and that she received a minor cut and just put a band-aid on the cut and that took care of it.The action taken with absorbable gelatin in response to the events and the outcome of the events were not provided.On 24oct2019, the product quality complaints department reported that the severity of harm has been selected by the manufacturing site as s3.Site sample status: not received.Sample status: sample availability unknown.Summary of investigation and conclusion: based on the complaint narrative, the patient sustained a cut/skin tear that caused pain while mixing the product as the syringe wing broke off.The patient applied band aid to the wound.Proper techniques of mixing were demonstrated.Review of complaint description concludes there is a device malfunction.Follow-up (22aug2019): new information received from a contactable nurse included: new event skin tear.Follow-up (28aug2019): new information received from a contactable nurse included that: event detail, treatment.Follow-up (22oct2019): 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 they concluded there was a device malfunction.Company clinical evaluation comment: the reported product complaint did not cause serious injury in this case.The nurse sustained a cut/skin tear that caused pain while mixing the product as the syringe wing broke off.This is a single potential device malfunction which has a theoretical risk to cause serious injury to user, if it were to recur.Follow-up attempts are completed.No further information is expected., comment: the reported product complaint did not cause serious injury in this case.The nurse sustained a cut/skin tear that caused pain while mixing the product as the syringe wing broke off.This is a single potential device malfunction which has a theoretical risk to cause serious injury to user, if it were to recur.
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Event Description
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Event verbatim [preferred term] difficult to her [device difficult to use] , strain to her palm, leaving marks and resulted in some unwanted pain [pain in extremity] , strain to her palm, leaving marks and resulted in some unwanted pain [muscle strain] , skin tear [skin laceration].Case narrative:this is a spontaneous report from a contactable nurse via a pfizer sales representative.A nurse reported that she had difficulties mixing the absorbable gelatin (gel-flow nt) syringe product.She explained that mixing the syringe a certain way caused strain to her palm because the flat /bottom part of the purple syringe would press firmly into her palms leaving marks, on an unspecified date.She said it was difficult for her; and resulted in some unwanted pain.As further reported on (b)(6) 2019, the nurse stated that no patient was involved.Injury was to a staff person who was mixing the gelflow.The difficulty in mixing the gel-flow (the extreme resistance of the substance), caused the syringe wing to break off resulting in a skin tear of the staff person.It was reported that the event did not take place after the use of the product, and the nurse was provided with alternative mixing techniques to avoid pain.On (b)(6) 2019, the nurse clarified that she was not the staff person mixing the gel-flow nt, and stated no one was injured.The nurse stated that it was a female certified scrub tech that mixed the gel-flow nt and she received a minor cut; and just put a band-aid on the cut and that took care of it.The action taken with absorbable gelatin was not applicable; the outcomes of the events were unknown.On (b)(6) 2019, product quality complaints group reported that the severity of harm has been selected by the manufacturing site as s3.Site sample status/sample availability: not received/ availability unknown.Summary of investigation and conclusion: based on the complaint narrative, the patient sustained a cut/skin tear that caused pain while mixing the product as the syringe wing broke off.The patient applied band aid to the wound.Proper techniques of mixing were demonstrated.Review of complaint description concludes there is a device malfunction.On (b)(6) 2019, additional information was provided the product quality complaints group.Complaint investigation summary manufacturing record review summary: reviewed 114 lots manufactured in the past 12 months and did not identify any anomalies.Complaint history: a search for gelflow nces and complaints was performed.(b)(4).Investigation summary: reviewed gel-flownt 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.Reviewed gel-flow nt cos and none were identified that would have been likely associated with the cause of the issue.There have been no changes to sterilization, equipment, or raw materials that could have contributed to this issue.The syringe is purchased from merit medical.Per merit, there have been no other complaints of the syringe breaking from other customers.There have been approximately (b)(4) syringes purchased from merit since 2016 to manufacture the gel-flownt device.This is the third complaint received which gives an occurrence (b)(4) during this time frame.Engineering also tried to recreate this failure but were unsuccessful in being able to do so without using the aid of tooling or equipment.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.This record includes processing for mdr/non-mdr records received on reports sent to mdpqc from 27jul2019 through 30sep2019.Follow-up (22aug2019): new information received from a contactable nurse included: new event skin tear.Follow-up (28aug2019): new information received from a contactable nurse included that: event detail, treatment.Follow-up (22oct2019): 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 they concluded there was a device malfunction.Follow-up (29oct2019): new information reported from the product quality complaints group includes: additional details regarding investigations.Follow-up attempts are completed.No further information is expected company clinical evaluation comment: the reported product complaint did not cause serious injury in this case.The nurse sustained a cut/skin tear that caused pain while mixing the product as the syringe wing broke off.This is a single potential device malfunction which has a theoretical risk to cause serious injury to user, if it were to recur., comment: the reported product complaint did not cause serious injury in this case.The nurse sustained a cut/skin tear that caused pain while mixing the product as the syringe wing broke off.This is a single potential device malfunction which has a theoretical risk to cause serious injury to user, if it were to recur.
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Manufacturer Narrative
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The severity of harm has been selected by the manufacturing site as s3.Summary of investigation and conclusion: based on the complaint narrative, the patient sustained a cut/skin tear that caused pain while mixing the product as the syringe wing broke off.The patient applied band aid to the wound.Proper techniques of mixing were demonstrated.Review of complaint description concludes there is a device malfunction.On 29oct2019, additional information was provided by the product quality complaints group.Investigation summary manufacturing record review summary: reviewed 114 lots manufactured in the past 12 months and did not identify any anomalies.Complaint history: a search for gelflownces and complaints was performed.(b)(4).Investigation summary: reviewed gel-flownt 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.Reviewed gel-flow nt cos and none were identified that would have been likely associated with the cause of the issue.There have been no changes to sterilization, equipment, or raw materials that could have contributed to this issue.The syringe is purchased from merit medical.Per merit, there have been no other complaints of the syringe breaking from other customers.There have been approximately (b)(4) syringes purchased from merit since 2016 to manufacture the gel-flownt device.This is the third complaint received which gives an (b)(4).Engineering also tried to recreate this failure but were unsuccessful in being able to do so without using the aid of tooling or equipment.Probable cause: based off this information the cause of t.
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Manufacturer Narrative
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The severity of harm has been selected by the manufacturing site as s3.Summary of investigation and conclusion: based on the complaint narrative, the patient sustained a cut/skin tear that caused pain while mixing the product as the syringe wing broke off.The patient applied band aid to the wound.Proper techniques of mixing were demonstrated.Review of complaint description concludes there is a device malfunction.On (b)(6) 2019, additional information was provided by the product quality complaints group.Investigation summary manufacturing record review summary: reviewed 114 lots manufactured in the past 12 months and did not identify any anomalies.Complaint history: a search for gelflownces and complaints was performed.A rate of 0.0009% is below this occurrence rate, and therefore does not appear that a trend exists.Investigation summary: reviewed gel-flownt 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.Reviewed gel-flow nt cos and none were identified that would have been likely associated with the cause of the issue.There have been no changes to sterilization, equipment, or raw materials that could have contributed to this issue.The syringe is purchased from merit medical.Per merit, there have been no other complaints of the syringe breaking from other customers.There have been approximately (b)(4) syringes purchased from merit since 2016 to manufacture the gel-flownt device.This is the third complaint received which gives an occurrence rate of 3/590,000= (b)(4) during this time frame.Engineering also tried to recreate this failure but were unsuccessful in being able to do so without using the aid of tooling or equipment.Probable cause: based off this information the cause of t.
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Event Description
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Event verbatim [preferred term] difficult to her [device difficult to use] , strain to her palm, leaving marks and resulted in some unwanted pain [pain in extremity] , strain to her palm, leaving marks and resulted in some unwanted pain [muscle strain] , skin tear [skin laceration].Case narrative:this is a spontaneous report from a contactable nurse via a pfizer sales representative.A nurse reported that she had difficulties mixing the absorbable gelatin (gel-flow nt) syringe product.She explained that mixing the syringe a certain way caused strain to her palm because the flat /bottom part of the purple syringe would press firmly into her palms leaving marks, on an unspecified date.She said it was difficult for her; and resulted in some unwanted pain.As further reported on 22aug2019, the nurse stated that no patient was involved.Injury was to a staff person who was mixing the gelflow.The difficulty in mixing the gel-flow (the extreme resistance of the substance), caused the syringe wing to break off resulting in a skin tear of the staff person.It was reported that the event did not take place after the use of the product, and the nurse was provided with alternative mixing techniques to avoid pain.On 28aug2019, the nurse clarified that she was not the staff person mixing the gel-flow nt, and stated no one was injured.The nurse stated that it was a female certified scrub tech that mixed the gel-flow nt and she received a minor cut; and just put a band-aid on the cut and that took care of it.The action taken with absorbable gelatin was not applicable; the outcomes of the events were unknown.On 24oct2019, product quality complaints group reported that the severity of harm has been selected by the manufacturing site as s3.Site sample status/sample availability: not received/ availability unknown.Summary of investigation and conclusion: based on the complaint narrative, the patient sustained a cut/skin tear that caused pain while mixing the product as the syringe wing broke off.The patient applied band aid to the wound.Proper techniques of mixing were demonstrated.Review of complaint description concludes there is a device malfunction.On 29oct2019, additional information was provided the product quality complaints group.Complaint investigation summary manufacturing record review summary: reviewed 114 lots manufactured in the past 12 months and did not identify any anomalies.Complaint history: a search for gelflow nces and complaints was performed.A rate of (b)(4) is below this occurrence rate, and therefore does not appear that a trend exists.Investigation summary: reviewed gel-flownt 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.Reviewed gel-flow nt cos and none were identified that would have been likely associated with the cause of the issue.There have been no changes to sterilization, equipment, or raw materials that could have contributed to this issue.The syringe is purchased from merit medical.Per merit, there have been no other complaints of the syringe breaking from other customers.There have been approximately (b)(4) syringes purchased from merit since 2016 to manufacture the gel-flownt device.This is the third complaint received which gives an occurrence rate of 3/590,000 = (b)(4) during this time frame.Engineering also tried to recreate this failure but were unsuccessful in being able to do so without using the aid of tooling or equipment.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.This record includes processing for mdr/non-mdr records received on reports sent to mdpqc from 27jul2019 through 30sep2019.On 11dec2019, product quality complaints group reported that the severity of harm has been selected by the manufacturing site as s2 (responsible site notif.Date (gmt): 24oct2019).Site sample status/sample availability: no sample was provided.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.Follow-up (22aug2019): new information received from a contactable nurse included: new event skin tear.Follow-up (28aug2019): new information received from a contactable nurse included that: event detail, treatment.Follow-up (22oct2019): 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 they concluded there was a device malfunction.Follow-up (29oct2019): new information reported from the product quality complaints group includes: additional details regarding investigations.Follow-up attempts are completed.No further information is expected.Follow-up (11dec2019): new information reported from the product quality complaints group includes: additional details regarding investigations.Company clinical evaluation comment: the reported product complaint did not cause serious injury in this case.The nurse sustained a cut/skin tear that caused pain while mixing the product as the syringe wing broke off.This is a single potential device malfunction which has a theoretical risk to cause serious injury to user, if it were to recur., comment: the reported product complaint did not cause serious injury in this case.The nurse sustained a cut/skin tear that caused pain while mixing the product as the syringe wing broke off.This is a single potential device malfunction which has a theoretical risk to cause serious injury to user, if it were to recur.
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Event Description
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Event verbatim [preferred term] difficult to her [device difficult to use], strain to her palm, leaving marks and resulted in some unwanted pain [pain in extremity], strain to her palm, leaving marks and resulted in some unwanted pain [muscle strain], skin tear [skin laceration].Narrative: this is a spontaneous report from a contactable nurse via a pfizer sales representative.A nurse reported that she had difficulties mixing the absorbable gelatin (gel-flow nt) syringe product.She explained that mixing the syringe a certain way caused strain to her palm because the flat /bottom part of the purple syringe would press firmly into her palms leaving marks, on an unspecified date.She said it was difficult for her; and resulted in some unwanted pain.As further reported on 22aug2019, the nurse stated that no patient was involved.Injury was to a staff person who was mixing the gelflow.The difficulty in mixing the gel-flow (the extreme resistance of the substance), caused the syringe wing to break off resulting in a skin tear of the staff person.It was reported that the event did not take place after the use of the product, and the nurse was provided with alternative mixing techniques to avoid pain.On (b)(6) 2019, the nurse clarified that she was not the staff person mixing the gel-flow nt, and stated no one was injured.The nurse stated that it was a female certified scrub tech that mixed the gel-flow nt and she received a minor cut; and just put a band-aid on the cut and that took care of it.The action taken with absorbable gelatin was not applicable; the outcomes of the events were unknown.On (b)(6)t2019, product quality complaints group reported that the severity of harm has been selected by the manufacturing site as s3.Site sample status/sample availability: not received/ availability unknown.Summary of investigation and conclusion: based on the complaint narrative, the patient sustained a cut/skin tear that caused pain while mixing the product as the syringe wing broke off.The patient applied band aid to the wound.Proper techniques of mixing were demonstrated.Review of complaint description concludes there is a device malfunction.On 29oct2019, additional information was provided the product quality complaints group.Complaint investigation summary manufacturing record review summary: reviewed (b)(4) lots manufactured in the past 12 months and did not identify any anomalies.Complaint history: a search for gelflow nces and complaints was performed.A rate of (b)(4) is below this occurrence rate, and therefore does not appear that a trend exists.Investigation summary: reviewed gel-flownt 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.Reviewed gel-flow nt cos and none were identified that would have been likely associated with the cause of the issue.There have been no changes to sterilization, equipment, or raw materials that could have contributed to this issue.The syringe is purchased from merit medical.Per merit, there have been no other complaints of the syringe breaking from other customers.There have been approximately 590,000 syringes purchased from merit since 2016 to manufacture the gel-flownt device.This is the third complaint received which gives an occurrence rate of 3/590,000 = (b)(4) during this time frame.Engineering also tried to recreate this failure but were unsuccessful in being able to do so without using the aid of tooling or equipment.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.This record includes processing for mdr/non-mdr records received on reports sent to mdpqc from 27jul2019 through 30sep2019.On 11dec2019, product quality complaints group reported that the severity of harm has been selected by the manufacturing site as s2 (responsible site notif.Date (gmt): (24oct2019).Site sample status/sample availability: no sample was provided.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.Complaints history (product and site) review: a search of non-conforming events (nces) and complaints was conducted.There have been five complaints including this complaint for this issue in the past 12 months (oct2018-oct2019).There have been (b)(4) devices ((b)(4)6-packs) manufactured during that same time frame.(b)(4).Per design fmeca (dfmeca), "product leaks or is damaged when deployed." has an occurrence of (b)(4) is below this occurrence rate and therefore does not appear that a trend exists.Internal deviations ('nces') was reviewed and none would have been likely associated with the cause of the issue: nces were reviewed for equipment failures that may have contributed to the issue; none identified; nces were reviewed at the component level for the syringe component and no supplier non conformances were identified.Review of process and analytical records: a review of all change orders (cos) for gel-flow nt was conducted and none were identified that would have been likely associated with the cause of the issue.There have been no changes to sterilization, equipment, or raw materials that could have contributed to this issue.It was identified in the design fmeca (dfmeca) that 'product leaks or is damaged when deployed' has two potential failure modes: 1) materials unable to withstand deployment force and 2) luer connections leak.The dfmeca identifies four controls for the above two failure modes: 1) material specification-barrel and plunger: cyclo-olefin polymer and acrylonitrile butadiene styrene (respectively) are common materials that are used in syringes for the medical device industry.2) luer design iso 594 compliance-meets standard iso 594-1 and 594-2 per supplier certification.3) syringe interface interaction (plunger/barrel)-silicone oil (360 medical grade silicone) is applied in the barrel to improve the plunger/barrel interface.4) syringe design iso 7886-1 compliance-meets standard iso 7886-1 per supplier certification.The engineering department also tried to recreate this failure but were unsuccessful in being able to do so without using the aid of tooling or equipment.The syringe is purchased from merit medical.Per merit, there have been no other complaints of the syringe breaking from other customers.There have been approximately 590,000 syringes purchased from merit since 2016 to manufacture the gel-flow nt device.This is the sixth complaint received which gives an occurrence rate of (b)(4) during this time frame.Follow-up (22aug2019): new information received from a contactable nurse included: new event skin tear.Follow-up (28aug2019): new information received from a contactable nurse included that: event detail, treatment.Follow-up (22oct2019): 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 they concluded there was a device malfunction.Follow-up (29oct2019): new information reported from the product quality complaints group includes: additional details regarding investigations.Follow-up attempts are completed.No further information is expected.Follow-up (11dec2019): new information reported from the product quality complaints group includes: additional details regarding investigations.Company clinical evaluation comment: the reported product complaint did not cause serious injury in this case.The nurse sustained a cut/skin tear that caused pain while mixing the product as the syringe wing broke off.This is a single potential device malfunction which has a theoretical risk to cause serious injury to user, if it were to recur.Follow-up (06nov2020): this is a follow-up report combining information from duplicate reports (b)(4).The current and all subsequent information will be reported under manufacturer report number (b)(4).The new information reported from the product quality complaint group includes additional details regarding investigation results.Follow-up attempts are completed.No further information is expected., comment: the reported product complaint did not cause serious injury in this case.The nurse sustained a cut/skin tear that caused pain while mixing the product as the syringe wing broke off.This is a single potential device malfunction which has a theoretical risk to cause serious injury to user, if it were to recur.
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Manufacturer Narrative
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The severity of harm has been selected by the manufacturing site as s3.Summary of investigation and conclusion: based on the complaint narrative, the patient sustained a cut/skin tear that caused pain while mixing the product as the syringe wing broke off.The patient applied band aid to the wound.Proper techniques of mixing were demonstrated.Review of complaint description concludes there is a device malfunction.On 29oct2019, additional information was provided by the product quality complaints group.Investigation summary manufacturing record review summary: reviewed 114 lots manufactured in the past 12 months and did not identify any anomalies.Complaint history: a search for gelflownces and complaints was performed.A rate of(b)(4) this occurrence rate, and therefore does not appear that a trend exists.Investigation summary: reviewed gel-flownt 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.Reviewed gel-flow nt cos and none were identified that would have been likely associated with the cause of the issue.There have been no changes to sterilization, equipment, or raw materials that could have contributed to this issue.The syringe is purchased from merit medical.Per merit, there have been no other complaints of the syringe breaking from other customers.There have been approximately 590,000 syringes purchased from merit since 2016 to manufacture the gel-flownt device.This is the third complaint received which gives an occurrence rate of (b)(4) during this time frame.Engineering also tried to recreate this failure but were unsuccessful in being able to do so without using the aid of tooling or equipment.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.This record includes processing for mdr/non-mdr records received on reports sent to mdpqc from 27jul2019 through 30sep2019.On 11dec2019, product quality complaints group reported that the severity of harm has been selected by the manufacturing site as s2 (responsible site notif.Date (gmt): 24oct2019).Site sample status/sample availability: no sample was provided.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.
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Search Alerts/Recalls
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