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

Catalog Number	0168L16
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the foley catheter balloon popped in patient's bladder.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Udi format updated with available product information per gudid.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 or Problem Description
It was reported that the foley catheter balloon popped in patient's bladder.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.It is unknown whether the device had met relevant specifications.It was unknown whether the product had caused the reported failure.The potential root cause for this failure could be due to thin sac causing by short latex dwell time, latex dip speeds out too slow and also might be contributed by user related (example: mishandling product or exposed to petroleum or sharp object).No actions can be taken at this time since a root cause was not identified.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 insertion: - perform hand hygiene immediately before and after insertion - insert urinary catheters using aseptic technique and sterile equipment - use the smallest foley catheter possible, consistent with good drainage - document the indications for catheter insertion, date and time of catheter insertion, individual who inserted catheter, and date and time of catheter removal in the patient record 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 * generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder.However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as nephrostomy tract.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.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER COUDE TIP
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 21891777
• Report Number: 1018233-2025-02932
• Device Sequence Number: 8190191
• Product Code: EZC
• UDI-Device Identifier: 00801741017827
• UDI-Public: (01)00801741017827(11)240920(17)280531(10)NGJV4234
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 0168L16
• Device Lot Number: NGJV4234
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2025
• Supplement Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown