Model Number 1050052 |
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 Date 11/18/2019 |
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 on (b)(6), the doctor in the operating room of the hospital was preparing to use glue for skin tissue bonding, but after opening the product package, the doctor found that all the glue in the product leaked out, and it was the same when opening three packages in succession.The event occurred prior to use.
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Manufacturer Narrative
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Samples received: 3 open pouches, unopened ampoules.Analysis and results: there is a previous complaint of this code batch regarding the same.There are no units in stock in b.Braun surgical warehouse.We have received 3 open pouches (closed ampoules) showing ampoule leakage.The ampoules received have been optically evaluated and a defect in the sealing bar of the ampoule was found.The leakage of the glue occurs at this point as can be seen in the enclosed picture.Reviewed the batch manufacturing record, this product had a normal process and was released fulfilling b.Braun surgical specifications.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 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.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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Search Alerts/Recalls
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