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 stock in b.Braun surgical's warehouse.We have received an open sample with needle detached from the thread (thread is still wound, needle is missing).Without closed samples a proper analysis cannot be performed.Batch manufacturing record: review the batch manufacturing record, there was an incidence but not related to this issue and product, this product had a normal process and the results during the process fulfils usp/ep and b.Braun surgical requirements.Conclusion root cause analysis: it has not been possible to determine the root cause.Final conclusion: in spite of receiving a defective sample, without closed samples a suitable analysis cannot be performed.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 distributed product 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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