(b)(4).Samples received: 1 unopened racepack.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 one closed sample.We have tested the knot pull tensile strength of the sample received and the result fulfils the requirements of the european pharmacopoeia (ep): xi= 1.61 kgf (ep requirements: 0.92 kgf in average and 0.31 kgf in minimum).Additionally, needle attachment strength test has been conducted on the closed sample received in order to discard a faulty needle attachment during manufacturing process that could cause splitting/fraying in the thread.The needle attachment strength result fulfills the requirements of the european pharmacopoeia (ep): xi= 1.49 kgf (ep requirements: 0.69 kgf in average and 0.35 kgf in minimum).We have not found splitting on thread surface on the closed sample received before and after performing tests.Reviewed the batch manufacturing record, there are no incidences related to this issue and the results during the process fulfils the oem requirements.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.Final conclusion: although the results of the closed sample received fulfill the specifications of b.Braun surgical specifications, we take note of this incidence in order to assess if new or additional actions are needed.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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It was reported by the healthcare professional "the costumer reports that the thread frays when passes through the tissues.It happened in 5 different patients.Carpal tunnel in hand surgery.The surgeon removed the rests of suture.The thread did not come off the needle." it was reported that there was no injury to the patient.All med watch submissions related to these patients are: 3003639970-2019-00339, 3003639970-2019-00340, 3003639970-2019-00342, 3003639970-2019-00343.
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