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Model Number MCP426H |
Device Problems
Break (1069); Difficult to Open or Remove Packaging Material (2922)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # (b)(4).H6.Component code: g07002 - device not returned attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Was there any adverse consequence associated with the patient? it was reported the issue reported in this event lead to the suture breaking on the surgeon several times, please clarify when were the sutures broke (in the package, during removal from package, during handling prior to use on patient or during use on the patient)? please specify what is the lot number? the single complaint was reported with multiple events.There are no additional details regarding the additional events.Event related to mw # 2210968-2023-04522, mw # 2210968-2023-04523, mw # 2210968-2023-04524, mw # 2210968-2023-04525, mw # 2210968-2023-04526 this is a combination product, and the event has been reviewed for both the suture and the triclosan.Trade name - irgacare® active ingredient(s) ¿ triclosan dosage form ¿ suture/solid/parenteral strength ¿ = 2360 ¿g/m this report is being submitted pursuant to the provisions of 21 cfr part 803, part 4 subpart b.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Event Description
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It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.There were multiple instances with this suture in which it was difficult to release it from the tray, which resulted in damaged or stretching of the suture.This lead to the suture breaking on the surgeon several times.No adverse patient consequences were reported.Additional information was requested.
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Manufacturer Narrative
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional information was requested and the following was obtained: was there any adverse consequence associated with the patient? no.It was reported the issue reported in this event lead to the suture breaking on the surgeon several times, please clarify when were the sutures broke (in the package, during removal from package, during handling prior to use on patient or during use on the patient)? please specify suture broke both when being removed from the suture tray and in the surgeons hand when suturing during the case.Please provide the lot number: lot number provided in initial pc report.(b)(6).
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Manufacturer Narrative
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(b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional h6 component code: g07002 reported condition not confirmed.Additional h3 investigation summary: the product was returned to ethicon for evaluation.Visual inspection was conducted on the device.Visual analysis of the returned sample revealed that only it was received one empty packaging that pertain to product code mcp426h.As the sutures or needles were not returned, the event described could not be confirmed.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.The product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.The returned sample revealed that it was received four unopened samples that pertain to product code mcp426h.In order to evaluate the condition of the returned samples, the packets were opened.The samples were tested to verify the dispensability of the suture and was successfully dispensed without any issues.In addition, the functional test was performed using an instron equipment and the tensile force was above the minimum requirements.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.The device performed without any difficulties noted.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.
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Search Alerts/Recalls
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