C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER
|
Back to Search Results |
|
Catalog Number 1758SI16 |
Device Problem
Inaccurate Flow Rate (1249)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/05/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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 bd.
|
|
Event Description
|
It was reported that the foley catheters were not allowing urine to drain.(nggy4249, nghp2506, nghq0947, nghq2191, nght0258, nght2381).
|
|
Manufacturer Narrative
|
The reported event was unconfirmed because the reported failure could not be reproduced.No root cause could be found because the reported event was unconfirmed.Visual evaluation of the returned sample noted one opened (without original packaging), 1 sure step foley tray system.Visual inspection noted no obvious defects.The drainage lumen of catheter was flushed with d.I.Water successfully with no leaks noted.This is within specification which states, catheter leaks, valve leaks, balloon perforation, lumen to lumen, prematurely deflated and dislodged balloon are not allowed, and must inflate and deflate with the use of a syringe.A device history record review was not required as the investigation was unconfirmed.As the reported event is unconfirmed neither a labeling review is not required.Section a through f - the information provided by bd represents all 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 bd.
|
|
Event Description
|
It was reported that the foley catheters were not allowing urine to drain.(nggy4249), (nghp2506), (nghq0947), (nghq2191), (nght0258), (nght2381).
|
|
Search Alerts/Recalls
|
|
|