Model Number 1050044 |
Device Problem
Fluid/Blood Leak (1250)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Type
malfunction
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
It was reported ampoule leakage occurred.The reporter indicated when using the product in the hospital operating room, four glues with batch number 21381n2 were found to be leaking.In the remaining 150 pieces of glue in the same batch in the hospital, it was found that there were 4 pieces of leakage in a box of 10 pieces of glue.It is unknown if patient involvement occurred.Additional information has been requested for clarification.
|
|
Manufacturer Narrative
|
Investigation: samples received: 4 open pouch, ampoule unopened with leakage signs and 2 closed pouches.Analysis and results: there are no 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 four open pouches (closed ampoules) showing ampoule leakage and two closed pouches.All ampoules received (open and closed pouches) have been optically evaluated and a defect in the sealing bar of 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 samples received do not fulfil b.Braun surgical specifications, and that there are several 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.
|
|
Search Alerts/Recalls
|
|