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.When additional information becomes available a follow up report will be submitted.
|
Investigation: sample received: 2 open pouches (the ampoule are unopened).Analysis and results: there are no 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's warehouse.We have received two open samples that contain an unopened ampoules.The ampoules received have been optically evaluated and a defect in the tip of the ampoules was found.Tip is bent.The leakage of the glue occurs at this point.The device history record of this product has been reviewed and no deviations have been found.Final conclusion: taking into account that the results of the samples received does 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.No corrective/preventive actions needed.
|