Model Number 1050044 |
Device Problems
Fluid/Blood Leak (1250); Mechanical Problem (1384)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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Reported device not marketed in the u.S., however, similar devices or devices that share components, (b)(4) 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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Event Description
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It was reported that there was ampoule leakage.The reporter indicated that the hospital opened the package and found that the glue had leaked out and the leaked glue had solidified.The event occurred prior to use with no patient harm.
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Manufacturer Narrative
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Invstigation: sample received: 1 open pouch (the ampoule is unopened).Analysis and results: there is a previous complaint of this code batch for the same issue, we manufactured and distributed in the market 4,180 units.There are no units in stock in b.Braun surgical's warehouse.We have received an open sample that contains an unopened ampoule.The ampoule received has been optically evaluated and a defect in the tip of the ampoule was found.Tip is bent.The leakage of the glue occurs at this point as can be seen in the enclosed picture.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 sample received does not fulfil b.Braun surgical specifications, we conclude that the complaint is confirmed by evidence of failure in the sample 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.
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Search Alerts/Recalls
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