Analysis and results: there are no previous complaints of this code-batch or units in our stock.We manufactured and distributed in the market 156 units of this code-batch.We have only received a picture showing an open sample of monoplus usp 1 8x45 cm, but the involved reference and batch is not known.According to the information received, this hospital uses m0024684 (this case) and m0024564 (b)(6).When the customer opens the package, found one monoplus of different size during surgery.However, the customer is not sure which box contains a unit of monoplus usp 1.We consider this case as confirmed due to the evidence of the picture received.However, without more information, a suitable investigation of the case cannot be performed, and the origin of this mix-up cannot be determined.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 picture received shows a unit that does not correspond to the code-batch of the product the customer received, we conclude that the complaint is confirmed by evidence of the picture 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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