Pma/510k: 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.K111959.If additional information becomes available a follow up report will be submitted.
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Investigation: samples received: no samples available.Analysis and results: there are no previous complaints of this code batch of which we manufactured and distributed in the market (b)(4) units.There are no units in stock in b.Braun surgical's warehouse.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 b.Braun surgical requirements.Moreover, there are no previous complaints of this code batch.Final conclusion: without samples and/or pictures showing the defect, 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 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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