Associated reports: 3003639970-2018-00745, 3003639970-2018-00773.Samples received: there are no samples available.Analysis and results: there are no previous complaints of this code-batch.We have not received any sample for analysis.Without any closed sample we cannot carry out an analysis in order to make a decision.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 monoplus® suture material, great care should be taken in order to ensure that the surgical instruments used, such as forceps or needle holders do not cause any crushing or crimping damage to the suture material.Final conclusion: without samples we are not in position of studying if the affected product does not fulfil the specifications.In consequence, a proper analysis cannot be done.Corrective/preventive actions: according to our internal procedures, there is no need to establish corrective or preventive actions.
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