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Model Number C3090915 |
Device Problems
Material Integrity Problem (2978); Material Twisted/Bent (2981)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/13/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Pma/510k: reported device not marketed in the u.S., however, similar devices or devices that share components, raw materials, process methods or other technological characteristics are registered within the u.S.K133890.When additional information becomes available a follow up will be submitted.
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Event Description
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It was reported that the thread is splitting and breaking.The reporter indicated that the threads are stratified and twisted.In addition to this, thread break occurs after several stitches.No patient information available.Additional event details have been requested.
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Manufacturer Narrative
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Investigation: samples received: (b)(4) unopened race packs.Analysis and results: there are no previous complaints of this code-batch.We manufactured and distributed in the market (b)(4) units of this code-batch.There are no units in our stock.We have tested the knot pull tensile strength of the closed samples received and the results fulfil the requirements of the european pharmacopoeia (ep): 0.36 kgf in average and 0.32 kgf in minimum (ep requirements: 0.15 kgf in average and 0.06 kgf in minimum) we have not found splitting on thread surface on the closed samples received before and after performing test.Furthermore, sewing test on artificial skin tissue has been conducted with the closed samples received and fraying/splitting does not appear when pulling the thread through the tissue.Visual appearance is the usual one as can be seen in enclosed picture.Reviewed the batch manufacturing record, this batch has an incidence but was released into the market fulfilling usp/ep and b.Braun surgical requirements.Final conclusion: although the results of the closed samples received fulfil the specifications of european pharmacopoeia/ b.Braun surgical specifications, we take note of this incidence in order to assess if new or additional actions are needed.Actions on product distributed of this reference/batch: based on the conclusion derived from investigation, it is not required to make actions in distributed product.Anyway, you will receive a credit note for the units sent for analysis as a quality courtesy.No corrective/preventive actions needed.
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Search Alerts/Recalls
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