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: 66 unopened pouches.Analysis and results: there are 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 warehouse.We have received 66 closed pouches.All pouches have been opened, all the ampoules received have been optically evaluated, and a defect in the sealing bar of the ampoule was found.The leakage of the glue occurs at this point as can be seen in the enclosed picture.Reviewed the batch manufacturing record, this product had an incidence not related to this issue and was released fulfilling b.Braun surgical specifications.Final conclusion: taking into account that the results of the samples received do not fulfil b.Braun surgical specifications, and that there are previous complaints for the same defect, we conclude that the complaint is confirmed by evidence of failure in the sample received.Actions on distributed product of this reference/batch: based on the conclusion derived from investigation, it is not required to make actions in distributed product.A capa has been initiated.
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