Analysis and results: there are no previous complaints of this code batch of which we manufactured and distributed in the market (b)(4) units.There are no units in stock in b.Braun surgical's warehouse.We have not received any sample, nevertheless we have received pictures showing the defect.The primary packaging is market as empty during production process but it was released in the market.We assume an accidental and isolated unit caused by a human mistake.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.Final conclusion: taking into account that the picture received shows that b.Braun surgical specifications are not fulfilled, we conclude that the complaint is confirmed by evidence of the pictures received.We apologise for any inconvenience that this issue may have caused, and thank you for your collaboration.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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