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 after the patient's family purchased the product in the hospital pharmacy, then went to the ward for the product could be used by the doctor for the patient.After opening the package, it was found that it had leaked and coagulated, and the patient's family returned it to the hospital pharmacy for replacement.The hospital pharmacy checked the same batch of 100 pieces of glue and found 27 pieces of leakage liquid coagulated.The event occurred prior to use with no patient harm.
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Manufacturer Narrative
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Investigation: samples received: 26 unopened and 3 open pouches, ampoules unopened with leakage signs.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 received 26 closed and 3 open pouches (closed ampoules) showing ampoule leakage.The ampoules received has been optically evaluated and a defect in the sealing bar of all the ampoules 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 sample received do not fulfil b.Braun surgical specifications, and that there are previous complaints for the same defect, we conclude that the complaint is confirmed by evidence of failure in the samples 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.A capa has been initiated.
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Search Alerts/Recalls
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