Summary of investigation: 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 not received any sample for analysis, only a picture showing a sample with needle detached from the thread (thread is not wound).However, without any closed sample we cannot carry out an analysis in order to take a decision.Taking into account that no other customer complaints have been received concerning this issue for this code-batch, we consider that this is an isolated unit, but the whole batch is correct.Batch manufacturing record: 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.Needle attachment strength results conducted on samples before releasing the product were 0.64 kgf in average and 0.52 kgf in minimum and fulfilled the requirements of the european pharmacopoeia (ep): 0.23 kgf in average and 0.11 kgf in minimum.Conclusion root cause analysis: it has not been possible to determine the root cause as no closed samples are received, only a picture showing an open sample with the needle detached from the thread.Final conclusion: in spite of receiving a picture showing a defective sample, without closed samples a suitable analysis cannot be performed and the case is considered not confirmed.Nevertheless, we take note of this incidence and if any closed sample is received in the future, we will re-open the case and analyse it.Corrective measures: 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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