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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Analysis and results: there are previous complaints of this code batch for the same issue.We manufactured and distributed in the market (b)(4) units.There are (b)(4) units blocked in stock in b.Braun surgical warehouse.We have received two open pouches (closed ampoules) showing ampoule leakage.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.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, we conclude that the complaint is confirmed by evidence of failure in the samples 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.Corrective/preventive actions: according to our internal procedures, we have opened a capa in the system in order to determine root cause and actions to correct/prevent this defect to happen.Capa number: ak201730130.
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