Analysis and results: 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 stock in b.Braun surgical's warehouse.We have not received any samples for analysis.Without closed and/or defective samples a proper analysis cannot be performed.As no samples have been received and no units are available in b.Braun surgical, we have only reviewed the batch manufacturing record and the results during the process fulfilled b.Braun surgical requirements.Needle penetration test results conducted on needles before releasing the product were 0.474 n and 0.390 n in maximum and fulfilled b.Braun surgical specifications: 0.480 n in maximum.Final conclusion: without samples we are not in position of studying if the affected product does not fulfil the specifications.In consequence, a proper analysis cannot be done and the case is not confirmed due to lack of evidence.Nevertheless, we take note of this incidence and if any sample is received in the future, we will re-open the case and analyse it.Please note that when no samples are received our analysis is very limited.Actions on product distributed 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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