Summary of investigation: there are no previous complaints of this code batch of which we manufactured and distributed in the market (b)(4) units.There are no units in stock in b.Braun surgical's warehouse.We have received an open and unused sample with the needle detached from the thread (thread is not wound on the pack and needle is missing).Without closed samples a proper analysis cannot be performed.Batch manufacturing record: reviewed the batch manufacturing record, this product had no incidences related to this issue and was released fulfilling usp/ep and b.Braun surgical specifications.Needle attachment results conducted on samples before releasing the product were 0.71 kgf in average and 0.49 kgf in minimum and fulfilled the requirements of the european pharmacopoeia: 0.23 kgf in average and 0.11 kgf in minimum.Conclusion of root cause analysis the most probable root cause is that the attachment of the needle was not correctly done as the sample received show that the needle escaped from the thread.Final conclusion despite 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 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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