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Product complaint # (b)(4).D4: full udi currently unavailable since the exact lot of the suspected device cannot be determined.Additional information: d4 ¿ the actual device batch number associated with this event is not known.The following are the possible batch numbers: slbhxm, tgbjxs, ubbhbq, tmbepq, tmbdum, tmbcbu, slbcup, ubbhbq.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.1.Are all of the lot numbers possible lots for each impacted product? 2.What lot numbers are associated with each impacted product? 3.Please clarify the quantity that is being returned for each impacted product.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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Product complaint # (b)(4) date sent to the fda: 2/20/2025.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, 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.H6 component code: g07002 no device problem found additional information.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested, the following was obtained: 1.Are all of the lot numbers possible lots for each impacted product? yes 2.What lot numbers are associated with each impacted product? unk 3.Please clarify the quantity that is being returned for each impacted product.Slbhxm x6, tgbjxs x2, ubbhbq x3 and tmbepq x1.H3 investigational summary: the product was returned to ethicon for evaluation.One open box with twenty-six representative unopened samples was received for analysis.Product code pn3557h, lot slbhxm.Upon initial inspection of the samples, no external damages were observed on the external packets.As per the sampling plan, a visual inspection was performed on thirteen samples.The packets were opened, and the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along the strand to detect any issue related no defects were observed during evaluation.A functional test was performed using instron equipment and the pull force result was above the minimum requirements.The event described could not be confirmed as the device performed without any defect noted.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.H3 investigational summary: the product was returned to ethicon for evaluation.Three representative unopened samples were received for analysis.Product code pn3557h, lot tmbcbu.Upon initial inspection of the samples, no external damages were observed on the external packets.In order to evaluate the conditions of the returned samples, the packets were opened, and no defects were detected.The swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along the strand to detect any issue related no defects were observed during evaluation.A functional test was performed using instron equipment, and the pull force results were above the minimum requirements.The event described could not be confirmed as the device performed without any defect noted.It should be noted that as part of our quality process, each batch is randomly inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.The event described could not be confirmed as no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.H3 investigational summary: the product was returned to ethicon for evaluation.One open box with nineteen representative unopened samples was received for analysis.Product code pn3557h, lot ubbhbq.Upon initial inspection of the samples, no external damages were observed on the external packets.As per the sampling plan, a visual inspection was performed on thirteen samples.The packets were opened, and the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along the strand to detect any issue related no defects were observed during evaluation.A functional test was performed using instron equipment and the pull force result was above the minimum requirements.The event described could not be confirmed as the device performed without any defect noted.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.H3 investigational summary: the product was returned to ethicon for evaluation.Four representative unopened samples were received for analysis.Product code pn3557h, lot tmbepq.Upon initial inspection of the samples, no external damages were observed on the external packets.In order to evaluate the conditions of the returned samples, the packets were opened, and no defects were detected.The swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along the strand to detect any issue related no defects were observed during evaluation.A functional test was performed using instron equipment, and the pull force results were above the minimum requirements.The event described could not be confirmed as the device performed without any defect noted.It should be noted that as part of our quality process, each batch is randomly inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.The event described could not be confirmed as no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.H3 investigational summary: the product was returned to ethicon for evaluation.Eight representative unopened samples were received for analysis.Product code pn3557h, lot tmbdum.Upon initial inspection of the samples, no external damages were observed on the external packets.In order to evaluate the conditions of the returned samples, the packets were opened, and no defects were detected.The swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along the strand to detect any issue related no defects were observed during evaluation.A functional test was performed using instron equipment, and the pull force results were above the minimum requirements.The event described could not be confirmed as the device performed without any defect noted.It should be noted that as part of our quality process, each batch is randomly inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.The event described could not be confirmed as no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.H3 investigational summary: the product was returned to ethicon for evaluation.One representative unopened sample was received for analysis.Product code pn3557h, lot tgbjxs.Upon initial inspection of the samples, no external damages were observed on the external packets.In order to evaluate the conditions of the returned sample, the packet was opened, and no defects were detected.The swage and attachment area were noted to be as expected.The suture was dispensed without problems and examined along the strand to detect any issue related no defects were observed during evaluation.A functional test was performed using instron equipment, and the pull force result was above the minimum requirements.The event described could not be confirmed as the device performed without any defect noted.It should be noted that as part of our quality process, each batch is randomly inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.The event described could not be confirmed as no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.H3 investigational summary: the product was returned to ethicon for evaluation.One representative unopened sample was received for analysis.Product code pn3557h, lot slbcup.Upon initial inspection of the samples, no external damages were observed on the external packets.In order to evaluate the conditions of the returned sample, the packet was opened, and no defects were detected.The swage and attachment area were noted to be as expected.The suture was dispensed without problems and examined along the strand to detect any issue related no defects were observed during evaluation.A functional test was performed using instron equipment, and the pull force result was above the minimum requirements.The event described could not be confirmed as the device performed without any defect noted.It should be noted that as part of our quality process, each batch is randomly inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.The event described could not be confirmed as no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Additional information: d4, h4 - the actual device lot number associated with this event is not known.The possible lot numbers are reported as follows: batch ubbhbq, batch slbcup, batch tmbcbu, batch tmbdum, batch tmbepq, batch ubbhbq, batch tgbjxs, batch slbhxm.A manufacturing record evaluation was performed for the finished device batch slbhxm, pn3557h and no non-conformances were identified.Mfg.Date - 10/27/2022 exp.Date - 09/30/2027.A manufacturing record evaluation was performed for the finished device batch tgbjxs, pn3557h and no non-conformances were identified.Mfg.Date - 06/27/2023 exp.Date - 05/31/2028.A manufacturing record evaluation was performed for the finished device batch ubbhbq, pn3557h and no non-conformances were identified.Mfg.Date - 02/21/2024 exp.Date - 01/31/2029.A manufacturing record evaluation was performed for the finished device batch tmbepq, pn3557h and no non-conformances were identified.Mfg.Date - 11/20/2023 exp.Date - 10/31/2028.A manufacturing record evaluation was performed for the finished device batch tmbdum, pn3557h and no non-conformances were identified.Mfg.Date - 11/16/2023 exp.Date - 10/31/2028.A manufacturing record evaluation was performed for the finished device batch tmbcbu, pn3557h and no non-conformances were identified.Mfg.Date - 11/08/2023 exp.Date - 10/31/2028.A manufacturing record evaluation was performed for the finished device batch slbcup, pn3557h and no non-conformances were identified.Mfg.Date - 10/13/2022 exp.Date - 09/30/2027.A manufacturing record evaluation was performed for the finished device batch ubbhbq, pn3557h and no non-conformances were identified.Mfg.Date - 02/21/2024 exp.Date - 01/31/2029.
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