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.
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Samples received: (b)(4) open pouches (b)(4) and (b)(4) unopened pouch.Analysis and results: there are previous complaints of this code batch regarding the same issue.We manufactured and distributed in the market (b)(4) units of this code-batch.There are (b)(4) units blocked in b.Braun surgical's warehouse.We have received three open pouches that contain three unopened ampoules and one unopened pouch.The ampoules have been optically evaluated and a defect in the sealing bar of the ampoule (yellow bar at the bottom of the ampoule) was found in three of the ampoules received.The leakage of the glue occurs at this point.We have conducted a review of the batch manufacturing record of this product and no deviations have been found.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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