MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX LUBRICATH FOLEY CATHETER

Catalog Number 0165L16

Device Problems Partial Blockage (1065); Insufficient Information (3190)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/29/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that there was a possible fault in foley catheters.Advised that it was down to clinical practice and catheter management not the catheters.Additional information requested.Per the follow-up received via ibc on 28oct2020, the nursing home advised of bypassing/blocking of the catheter¿s as this was across a range of catheter¿s and isolated to this care home.It was believed that it was a training issues possible something to do with how they use optiflo and retraining was being arranged by the nurse team however this could not be confirmed.No photos are available.

Event Description

It was reported that there was a possible fault in foley catheters.Advised that it was down to clinical practice and catheter management not the catheters.Additional information requested.Per follow-up received via ibc on 28oct2020 , the nursing home advised of bypassing/blocking of the catheter as this was across a range of catheters and isolated to this care home.It was believed that it was a training issues possible something to do with how they use optiflo and retraining was being arranged by the nurse team however this could not be confirmed.Per follow up with the ibc via email on 22feb2021, the foley catheter had been bypassing and blocking.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure mode could be user related (example: salt accumulation)/ blocked drainage lumen/ no drainage eye.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "proper techniques for urinary catheter maintenance secure the foley catheter.Use the statlock®.Foley stabilization device if provided.Maintain a closed drainage system by utilizing pre-connected, sealed catheter-tubing junctions.Maintain unobstructed urine flow and keep the catheter and collection tube free from kinking.Keep the collection bag below the level of the bladder or hips at all times.Empty the collection bag regularly using a separate, clean collection container for each patient." h11:section a through f - the information provided by bd 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 bd.H3 other text : the device was not returned.

• Brand Name: BARDEX LUBRICATH FOLEY CATHETER
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11387834
• MDR Text Key: 241775422
• Report Number: 1018233-2021-00848
• Device Sequence Number: 1
• Product Code: EZC
• Combination Product (y/n): N
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2023
• Device Catalogue Number: 0165L16
• Device Lot Number: NGEQ4182
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other