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 our stock.We have received a closed sample to analyze this complaint.Pull out of suture in the closed sample received is correct and the current one.Suture has been pulled out without difficult and does not become tangled.Remarks: please note that are necessaries two movements to pull out the suture from the packaging according to the design of double armed sutures packed in race pack, one for pulling out first needle and thread and another one to pull out the second needle.This product has been manufactured with the current design of winding and packaging.On the other hand, about curling defect, in the middle of the thread length we can see that there is the typical curve (loop) formed in products with double needle.This loop is placed in an area of the racepack plastic carrier during the winding process.We have tested the knot pull tensile strength of the closed sample received and the results fulfil the requirements of the european pharmacopoeia (ep): 1.34 kgf (ep requirements: 0.51 kgf in average and 0.15 kgf in minimum) batch manufacturing record: 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.Conclusion root cause analysis: it has not been possible to determine the root cause because the closed sample received complies the european pharmacopoeia and b.Braun surgical requirements.Final conclusion: final conclusion: although the results of the sample received fulfil the specifications of european pharmacopoeia/ b.Braun surgical specifications, we take note of this incidence in order to assess if new or additional actions are needed.The case is considered not confirmed by evidence of the closed sample received.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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