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 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 not received any sample.Nevertheless, ampoules received from previous complaints of the same code batch were 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 there are previous complaints confirmed of the same code batch for the same issue, we conclude that the complaint is confirmed by evidence of failure in the ampoules.We apologize for any inconvenience that this issue may have caused, and thank you for your collaboration.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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