Model Number 1050052 |
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 in the operating room of (b)(4), it was found that several pieces of glue with batch number of 218404n1 and code of 1050052 were leaking continuously.After that, the staff randomly checked 20 pieces of the same batch and model and found several pieces of leakage glue.Therefore, there was concern about the remaining 280 pieces of the same batch and model at the hospital.The event occurred prior to use with no patient harm.
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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 4,050 units.There are no units in stock in b.Braun surgical warehouse.We have received 138 closed pouches and 3 open pouches (unopened ampoules).Some of the ampoules received have been optically evaluated and a defect in the sealing bar in the ampoules received was found (16 tested and 4 with leakage).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, 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.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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