Model Number 1050044 |
Device Problems
Fluid/Blood Leak (1250); Mechanical Problem (1384)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
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.When additional information becomes available a follow up report will be submitted.
|
|
Event Description
|
It was reported that there was ampoule leakage.The reporter indicated that the glue was sent to the operating room; when it was opened for use, one piece of glue was found leaking.The glue seal is good, but the glue has leaked.The event occurred prior to use.
|
|
Manufacturer Narrative
|
Investigation: samples received: 1 open pouch, unopened ampoule.Analysis and results: there are previous complaints of this code batch of which we manufactured and distributed in the market 4,060 units.There are no units in stock in b.Braun surgical warehouse.We have received one open pouch (closed ampoule) showing ampoule leakage.The ampoule received has been optically evaluated and a defect in the sealing bar of the ampoule 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 several previous complaints 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.A capa has been initiated.
|
|
Search Alerts/Recalls
|
|