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: 1 open pouch, ampoule unopened with leakage signs and two closed pouches.Analysis and results: there is a previous complaint 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 one open pouch (closed ampoule) showing ampoule leakage and two closed pouches.The ampoule of the open pouch received has been optically evaluated and a defect in the sealing bar of the ampoule was found.The leakage of the glue occurs at this point.The ampoules of the closed pouches received were not affected by this defect.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 sample received does not fulfil b.Braun surgical specifications, and that there are several 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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