(b)(4).Manufacturing site evaluation: samples received: 2 unopened race-packs to analyze.Analysis and results: there are no previous complaints of the same code-batch.We have received 4 cases from the same customer involving 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 samples received and the results fulfill the requirements of the european pharmacopoeia (ep).Additionally, needle attachment strength test has been conducted on the samples received in order to discard a faulty needle attachment during manufacturing process that could cause splitting/fraying in the thread.The needle attachment strength results fulfill the requirements of the european pharmacopoeia (ep).We have not found splitting on thread surface on the closed samples received before and after performing tests.Review of the batch manufacturing record showed there are no incidences related to this issue and the results during the process fulfilled usp/ep and b.Braun surgical requirements.Furthermore, we have reviewed the complaint history record of several products manufactured with the same thread raw material batch as they used in this product, and there are no previous complaints in any of them.As indicated in the instructions for use of the product, when working with optilene suture material, great care should be taken to avoid any crushing or crimping damage of the monofilament by instruments such as forceps or needle holders.According to the results of the samples tested and the batch manufacturing record review, the product complies with our specifications and also fulfill usp/ep requirements.Therefore we do not see any manufacturing fault or material defect that could have caused the incidence.Final conclusion: although the results of the samples received fulfill 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.
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