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.The device met relevant specifications.The product had not caused the reported failure.Visual evaluation of the returned sample noted one opened (with original packaging), surestep foley tray system.Visual inspection of the sample noted the catheter balloon was inflated with 10 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and allowed to drain freely, no defects noted.No root cause could be found because the reported event was unconfirmed.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The reported event is unconfirmed a labeling review is not required.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.H3 other text : the actual/suspected device was inspected.
|
|
Event Description
|
It was reported that the foley catheters were not allowing urine to drain.(nggy4249, nghp2506, nghq0947, nghq2191, nght0258, nght2381).
|
|
Search Alerts/Recalls
|
|
|