Reported device not marketed in the u.S., however, similar devices or devices that share components, raw materials, process methods or any other technological characteristics with a medical device that is registered within the u.S.(b)(4).Manufacturing site evaluation: evaluation on-going.Device not returned.
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Samples received: 4 unopened pouches.Analysis and results: there are no previous complaints of this batch of which we manufactured and distributed (b)(4) units.The four ampoules received have been analysed and the glue in all the samples received has been extracted without problem, the cannula is not blocked.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfill b.Braun surgical requirements.Final conclusion: although the results of the samples received fulfil b.Braun surgical specifications, this incidence is noted in order to assess if new or additional actions are needed.Actions on product distributed 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 internal procedures, there is no need to establish corrective or preventive actions.Nevertheless, this complaint is recorded for trending analysis to assess if actions are needed in the future.
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