Model Number 1050044 |
Device Problems
Fluid/Blood Leak (1250); Mechanical Problem (1384)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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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 the ampoule is leaking.The reporter indicated that at the beginning of (b)(6), the operation room of the second affiliated hospital of (b)(4) found that the glue in the operating room was leaking when opening the outer packaging.Per the reporter, the doctors thought it was an individual event at that time, but later found that there were more and more ampoule packages with leaks.The event occurred before use on a patient.
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Manufacturer Narrative
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Samples received: 10 closed pouches.Analysis and results: there is a previous complaint of this code batch.There are (b)(4) units blocked in stock in b.Braun surgical warehouse.We have received 10 closed ampoules.All ampoules received have been optically evaluated and a defect in the sealing bar in 2 of the 10 of the ampoules received 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 the results of the samples received do not fulfil b.Braun surgical specifications, and that there is a previous complaint for the same defect, 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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