Summary of investigation: there are no previous complaints of this code-batch of which we manufactured and distributed in the market 7,668 units.There are no units in our stock.We have received 53 closed samples for analysis.Tightness test to the closed samples received has been performed and the units are tight.When we have conducted rotation test in closed samples received, we have noticed that in most of them threads break easily in the attachment area.Then, detachment of the needle or breakage of the thread in that area could have been caused by too much thermal treatment in the manufacturing process, which causes the thread burnt and breaking easily in the attachment area.Batch manufacturing record: 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.Conclusion root cause analysis: detachment of the needle or breakage of the thread in that area could have been caused by too much thermal treatment in the manufacturing process, which causes the thread burnt and breaking easily in the attachment area.Final conclusion: taking into account that the results of the closed samples received do not fulfil usp/ep and b.Braun surgical specifications, we conclude that the complaint is confirmed by evidence of the closed samples received.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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