Analysis and results: there are no previous complaints of this code-batch or units in our stock.We manufactured and distributed in the market (b)(4) units of this code-batch.We have received a box that does not contain the front box label.This defect was caused in the warehouse when preparing the shipment.Upon checking traceability, it has been verified that this box was labelled.However, it is likely that it was peeled off for some reason and the personnel involved did not notice it.Therefore, the box was not discarded and consequently supplied to the customer by mistake.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.Considering that there are no previous complaints of this code-batch, we consider that this is an isolated an accidental box but whole batch is correct.Final conclusion: taking into account that the box received does not fulfil b.Braun surgical specifications, we conclude that the complaint is confirmed by evidence of the failure in the box 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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