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.Investigation: analysis and results: there are no previous complaints of this code batch of which we manufactured and distributed 4,090 units in the market.There are no units in stock in b.Braun surgical's warehouse.No samples or picture showing the defect has been received.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfill 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.No corrective/preventive actions needed.
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It was reported that there was ampoule leakage.The reporter indicated that after opening the glue package it was found when the glue is opened, it is found that the glue inside the package leaks and cannot be used normally.The product has been discarded by the hospital, so there is no sample return.
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