Samples received: 1 open pouch.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 warehouse.We have received an open and used suture with the needle detached from the thread as can be seen in the enclosed picture.However, without closed samples a proper analysis cannot be performed.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 analyze 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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