Model Number 1050044 |
Device Problems
Fluid/Blood Leak (1250); Mechanical Problem (1384)
|
Patient Problem
No Patient Involvement (2645)
|
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 that the ampoule is leaking.The reporter indicated that at the beginning of (b)(6) 2019 the operation room of the second affiliated hospital of (b)(4) found that the glue in the operation room was leaking when opening the outer packaging.The doctors thought it was an individual event at that time, but later found that there were more and more leaks.The event occurred before use on a patient.
|
|
Manufacturer Narrative
|
Samples received: 1 open pouch (unopened ampoule).Analysis and results: there are previous complaints of this code batch.There are no units in stock in b.Braun surgical warehouse.We have received (b)(4) 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 does 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 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.
|
|
Search Alerts/Recalls
|
|