Samples received: 18 unopened units.Analysis and results: there are no previous complaints of this code-batch.We manufactured 1,260 units of this code-batch.There are 240 units in our stock.We have received 18 closed samples to analyze this complaint.We have tested the knot security control of the samples received and the results are into the current range for this thread and size.Remarks: as indicated in the note/precautionary measures from the instruction for use of the product, dafilon® should be used applying the standard surgical suturing and knotting techniques, taking into account the surgeon's experience with the respective surgical procedure.Care should be taken that the knots are positioned properly and adequate knot security is given.On the other hand, flexibility test can not be conducted to threads of usp 9/0.The visual inspection of the threads of the closed samples received is the usual and current ones as can be seen in enclosed picture.Thread is not damaged.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfilled b.Braun surgical requirements.Final conclusion: although the results of the samples received fulfil the b.Braun surgical specifications, we take note of this incidence in order to assess if new or additional actions are needed.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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