C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER
|
Back to Search Results |
|
Catalog Number 1758SI14 |
Device Problem
Partial Blockage (1065)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/13/2023 |
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 urine did not pass through the foley catheter after insertion.Although they tried passing water through it with a syringe, it did not pass.Per follow-up information received from ibc on 20oct2023, stated that blockage was found in the foley catheter.
|
|
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 (without original packaging), used drainage bag with inlet tube, sample port connector, catheter and tes.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 rested with no leaks.With the syringe attached the balloon deflated passively under 1 minute with no leaks or cuffing noted.The photo sample was returned and could not be evaluated for the reported failure.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.As the reported event is unconfirmed 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 urine did not pass through the foley catheter after insertion.Although they tried passing water through it with a syringe, it did not pass.Per follow-up information received from ibc on 20oct2023, stated that blockage was found in the foley catheter.
|
|
Search Alerts/Recalls
|
|
|