Samples received: 1 open pouch (and 1 unopened pouch from another batch that will not be analyzed).Analysis and results: there are no previous complaints of this code batch of which we manufactured and distributed (b)(4) units in the market.There are no units in stock in b.Braun surgical's warehouse.We have received an open sample (seems unused) with one of the needles detached from the thread.The other needle (double armed product) is connected to the thread.Nevertheless, needle attachment strength test to the attached needle cannot be done because the thread is broken approximately 1cm from the needle and the test cannot be carried out.Taking into account that no other customer complaints have been received concerning this issue for this code-batch we consider that this is an isolated unit.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfill usp/ep and b.Braun surgical requirements.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/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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