Summary of investigation: there is one previous complaint of this code-batch regarding the same issue, closed as not confirmed after the analysis of the open sample received.We manufactured and distributed in the market (b)(4) units.There are no units in our stock.We have received 31 closed samples and 4 open samples (3 with the thread still wound or partially wound on pack and only 1 with the needle that was attached to the thread).Tightness test to the closed samples received have been performed and the units are tight.Needle attachment results conducted on the closed samples received are 1.64 kgf in average and 1.27 kgf in minimum and fulfil european pharmacopoeia (ep) requirements: 1.12 kgf in average and 0.46 kgf in minimum.However, taking into account that 2 of the open samples received had the thread still wound on the pack and the needles detached, and that there is a previous complaint of this code-batch for the same issue, we will consider this complaint as confirmed.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: the most probable root cause is that the attachment of the needle was not correctly done as the open samples received show that the needle escaped from the thread.Final conclusion: taking into account the open samples received do not fulfil european pharmacopoeia/ b.Braun surgical specifications we conclude that the complaint is confirmed by evidence of the failure in the open 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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