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Catalog Number 813T |
Device Problems
Break (1069); Material Separation (1562); Defective Component (2292)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 01/29/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.The single complaint was reported with multiple events.There are no additional details regarding the additional events.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.How many devices presented a difference in the thickness of the sutures during this single procedure? how many devices presented suture breakage during this single procedure? how many devices presented needle and thread detachment during this single procedure? how many minutes was the procedure delayed? were there any unexpected outcomes or complications as a result of the prolonged surgery time? was the patient treatment altered in anyway due to the prolonged surgery time? if yes, please explain was there any adverse consequence associated with the patient as a result of the bleeding? additional information request from technovigilance: in the physician¿s opinion, could delay of the procedure have contributed to a death or a serious injury to the patient? if yes, please provide details.Did the patient require extended hospitalization due to a medical condition caused by procedure delay? if yes, please provide details.Is the current patient status known? was there any patient consequence or change in the post-operative care of the patient as a result of the event? (extended hospital stay, readmission, re-operation, etc.).
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Event Description
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It was reported that a patient underwent a c-section on (b)(6) 2021 and suture was used.The surgeon stated that there was a difference in the thickness of the sutures and the suture broke and the needle thread detached.The procedure was completed successfiully.The device was already discarded because they were contaminated.The failure of the suture caused a delay in the care of a patient with bleeding.There were no adverse patient consequences.Additional information was requested.
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Manufacturer Narrative
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(b)(4).Date sent to the fda: 6/23/2021.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: h4, h6 a manufacturing record evaluation was performed for the finished device lot number an7127, and no non-conformances related to the reported complaint condition were identified.A photo upon which this medwatch is based has been received, however, the photo evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
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Manufacturer Narrative
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(b)(4).Date sent to fda: 07/23/2021.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: h6.H3 photo analysis summary: the product was not returned to ethicon inc for evaluation.Visual inspection was conducted on the picture received.Visual analysis of the picture received determined that a dispensed needle/suture, a detached needle, a dispensed suture and overwrap packet of product code 813t could be observed.The condition of the breakage suture could not be observed, the suture diameter was not measured since the sample was not received for evaluation.Only the detached needle from suture was observed, however the assignable cannot be determined.No conclusion could be reached as to what caused the reported complaint since the sample was not returned for analysis.H6 component code: g07002 - procedure related photo review.
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Search Alerts/Recalls
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