Analysis and results: there are no previous complaints of this code-batch.4 cases received the same day involving the same code-batch.We manufactured and distributed in the market (b)(4) units of this code-batch.There are no units in stock in b.Braun surgical's warehouse.We have not received any samples.As no samples have been received and no units are available in b.Braun surgical, s.A.We have only reviewed the batch manufacturing record and the results during the process fulfill usp/ep and b.Braun surgical requirements.The average penetration results of the needles before releasing the product were 0.412n, 0,396n, 0,377n and 0,406n (average penetration specification: <0.480 n).Needle attachment results conducted on the samples before releasing the product were 0.70 kgf in average and 0.47 kgf in minimum and fulfil ep requirements: 0.46 kgf in average and 0.23 kgf in minimum.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.We regret any inconvenience this issue may have caused and thank you for your collaboration.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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