C.R. BARD, INC. (COVINGTON) -1018233 RELIAVAC CLOSED WOUND SUCTION EVACUATOR, 100ML SILICONE EVACUATOR WITH ANTI-REFL
|
Back to Search Results |
|
Catalog Number 0070740 |
Device Problems
Break (1069); Out-Of-Box Failure (2311)
|
Patient Problems
No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
|
Event Date 02/08/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
|
|
Event Description
|
It was reported that, prior to use, suction port a breakage was found.
|
|
Event Description
|
It was reported that, prior to use, suction port a breakage was found.Per sample evaluation: the evacuator port was received broken from the cap.
|
|
Manufacturer Narrative
|
Received 1 evacuator for evaluation.The reported event was confirmed.During visual evaluation it was found that the inlet port was broken.Under 10 x magnification, stress marks were observed in the inlet port.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "vi.Warnings: 7.An airtight seal between all system components (drain, adapter, y-connector, crab-claw, evacuator and tube ends) is necessary for intended system function.Do not use if package is damaged." correction: other#.
|
|
Search Alerts/Recalls
|
|
|