Model Number 1050044 |
Device Problems
Fluid/Blood Leak (1250); Mechanical Problem (1384)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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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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Event Description
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It was reported that there was ampoule leakage.The reporter indicated that the head nurse of the operating room of the hospital stated that a large amount of glue leakage had been found during the operation recently.The event occurred prior to use.
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Manufacturer Narrative
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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.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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Search Alerts/Recalls
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