Samples received: 9 unopened and 1 open pouches.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 9 closed samples and an open and unused unit.We have tested the knot pull tensile strength of the closed samples received and the results fulfill the requirements of the european pharmacopoeia (ep): 1.10 kgf in average and 1.09 kgf in minimum (ep requirements: 0.51 kgf in average and 0.15 kgf in minimum).We have tested the needle attachment strength of the closed samples received and the results fulfill the requirements of the european pharmacopoeia (ep): 0.68 kgf in average and 0.59 kgf in minimum (ep requirements: 0.46 kgf in average and 0.23 kgf in minimum).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: although the results of the samples 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.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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