Analysis and results: there are no previous complaints of this code batch of which we manufactured and distributed in the (b)(4) units.There are no units in stock in b.Braun surgical's warehouse.We have received an open sample.The unit received has 9 sutures, moreover the suture is not fixed to the sponge because there is no room for it.The unit has been checked and confirmed that the unit went through the counting machine.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.We have informed maintenance and engineering departments of this issue.Taking into account that there are no previous complaints for this issue, for this or any other batches, we consider that this is an isolated unit.Final conclusion: taking into account that the results of samples received do not fulfil the specifications of the european pharmacopoeia/b.Braun surgical specifications, we conclude that the complaint is confirmed by evidence of the samples received.Actions on distributed product 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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