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 received 41 closed samples for analysis.Visually, thread surface appearance of closed samples received is correct and the usual one.We have tested the needle attachment strength of the samples received and the results fulfil the requirements of the european pharmacopoeia (ep): 1.20 kgf in average and 0.73 kgf in minimum (ep requirements: 0.46 kgf in average and 0.23 kgf in minimum) sewing test on artificial skin tissue has been conducted with the samples received and splitting/fraying does not appear when pulling the thread through the tissue.Visual appearance of the thread is the usual one.We have also tested the knot pull tensile strength of the samples received and the results fulfil the requirements of the european pharmacopoeia (ep): 1.28 kgf in average and 1.23 kgf in minimum (ep requirements: 0.51 kgf in average and 0.15 kgf in minimum) reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfil usp/ep and b.Braun surgical requirements.Remarks: 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.Final conclusion: although the results of the 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.Corrective/preventive actions: according to our internal procedures, there is no need to establish corrective or preventive actions.Nevertheless, this complaint is recorded for trending analysis to assess if actions are needed in the future.
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