MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER

Catalog Number 175812

Device Problem Inaccurate Flow Rate (1249)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/19/2023

Event Type  malfunction  

Event Description

It was reported that the district nurse visited for catheter change due to urinary tract infection, observations and to obtain a sample.Antibiotics commenced that morning.The patient had history of multiple sclerosis (ms), an enlarged prostate and a large bladder stone, recurrent urinary tract infections.The previous catheter was removed with no issues, some sediment was noted in urine in leg bag.A new catheter inserted, had some resistance and was unable to advance the catheter any further.The balloon inflated and then waited for draining.While waiting encouraged fluids and got patient to stand up.After around 30 minutes no urine had drained.The patient was not in discomfort.Stated that the patient did not had usual pain response, so it was not a good indicator of anything.They tried to deflate the balloon and reposition catheter.However when attaching syringe, it did not spontaneously fill as usual, so they pulled back and only 2ml was in syringe.They tried a different 10ml syringe however faced the same issue.They re-inserted the 2mls and phoned back to office for advice.The clinic nurse checked catheter policy and advice was to leave a 10ml syringe on for a few minutes to see if it would spontaneously fill, this was unsuccessful.Advised to change leg bag, also unsuccessful.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be ¿lumen wall thickness undersized ¿.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: "visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfection or surface deterioration is observed, do not use.Ensure catheter and drainage bag tubing is kink free and drainage bag is positioned below the bladder to ensure urine is flowing freely.Periodic inspection of this system should be made to ensure that urine is flowing freely.If a standing column of urine is observed, check for correct positioning of bag and then for a physical obstruction.If correct positioning or removal of physical obstruction does not allow free flow, further investigation should be taken in line with local protocol." h11: section a through f - 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.H3 other text : the device was not returned.

• Brand Name: BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 18147735
• MDR Text Key: 328262694
• Report Number: 1018233-2023-08157
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K984084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 175812
• Device Lot Number: NGGW3018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2023
• Initial Date FDA Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male