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 36 closed samples to analyze this case.Two of the closed samples received have an orange mark in the upper right part of the packaging.We have not been able to determine the origin of this mark.Probably, this issue took place during manufacturing process.Furthermore, this units should have been discarded in the packaging area, but they were not detected.Considering that no other customer complaints have been received for this issue, we consider that these units are isolated and accidental units and the whole batch is correct.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.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 product distributed 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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