(b)(4).Reported device not marketed in the u.S., however, similar devices or devices that share components, raw materials, process methods or other technological characteristics are registered within the u.S.K990090.Samples received: there are no samples available for analysis.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 in our stock.We have not received any sample for analysis.Without any closed sample we cannot carry out an analysis in order to take a decision.A review of the batch manufacturing record for this product had a normal process and the results during the process fulfil usp/ep and b.Braun surgical requirements.Needle attachment strength results before releasing the product were 0.35 kgf in average and 0.328 kgf in minimum and fulfilled the requirements of the european pharmacopoeia (ep requirements: 0.17 kgf in average and 0.082 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.Nevertheless, we take note of this incidence and if any sample is received in the future, we will re-open the case and analyze 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.No corrective/preventive actions needed.
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