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's warehouse.We have not received any samples; in consequence a proper analysis cannot be performed.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.Needle attachment results conducted on samples before releasing the product were 0.33 kgf in average and 0.196 kgf in minimum and fulfilled the requirements of the european pharmacopoeia (ep): 0.17 kgf in average and 0.082 kgf in minimum.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfil european pharmacopoeia/b.Braun surgical requirements.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.
|