Analysis and results: there are no previous complaints of this code-batch.We manufactured and distributed in the market (b)(4) of this code-batch.There are no units in our stock.We have received two open and unused samples.The needle is attached to the thread and the suture is wound on the pack.We have tested the needle attachment strength of the samples received and the results fulfil the requirements of the european pharmacopoeia (ep): 0.54 kgf in average and 0.52 kgf in minimum (ep requirements: 0.23 kgf in average and 0.11 kgf in minimum) 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.Needle attachment strength results before releasing the product were 0.51 kgf in average and 0.38 kgf in minimum and fulfilled ep requirements.Final conclusion: although the results of the samples received fulfil the specifications of european pharmacopoeia/ b.Braun surgical specifications, we take note of this incidence in order to assess if new or additional actions are needed.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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