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

Catalog Number	2557H20
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/09/2026
Type of Reportable Event	Malfunction
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 there were patient harm and device burst during surgery.
Additional Manufacturer Narrative
The reported event was inconclusive because this investigation did not result in any additional findings and no sample was available for evaluation.Instructions for use were reviewed for this investigation.The reported event is addressed within the labeling as it states" should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.Visually inspect the product for any imperfections or surface deterioration prior to use.Recommended inflation capacities 3cc balloon: use 5ml sterile water 5cc balloon: use 10ml sterile water 15cc balloon: use 20ml sterile water 20cc balloon: use 25ml sterile water 30cc balloon: use 35ml sterile water 40cc balloon: use 45ml sterile water 75cc balloon: use 80ml sterile water do not exceed recommended capacities.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Corrections: d, h 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 there were patient harm and foley catheter burst during surgery.

• Brand Name: BARDEX® LUBRICATH® HEMATURIA COUDE FOLEY CATHETER
• 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: 24595649
• Report Number: 1018233-2026-01702
• Device Sequence Number: 8697793
• Product Code: KOD
• UDI-Device Identifier: 00801741025174
• UDI-Public: (01)00801741025174(11)240717(17)270731(10)NGJT0534
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K922431
• 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): 04/30/2026

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: 2557H20
• Device Lot Number: NGJT0534
• 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: 03/10/2026
• Supplement Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/17/2024
• 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