Associated reports: 3003639970-2018-00743.Samples received: 1 unopened pouch and 1 opened.Analysis and results: there are no previous complaints of this code-batch.We have received one closed sample and one open and used sample with the thread broken.We have tested the knot pull tensile strength of the closed sample received and the results fulfil the requirements of the european pharmacopoeia (ep): xi= 1.23 kgf (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 fulfill usp/ep and b.Braun surgical requirements.Remarks: when working with suture materials great care should be taken to ensure that the use of surgical instruments, such as tweezers and needle holders, does not cause the material to be damaged by being pinched or kinked.Final conclusion: although the result of the closed sample received fulfils 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.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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