MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 Bardia® Foley Catheter Silicone Coated; Latex Silicone Foley Catheter

Catalog Number	123616A
Medical Device Problem Codes	Burst Container or Vessel (1074); Material Rupture (1546)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was admitted to the hospital at 12:24 p.M.On (b)(6) 2026 with "left sided lower back and abdominal pain for three days," and was diagnosed with "bilateral hydronephrosis with ureteral stones," and underwent transurethral ureteropelvic pelvic laser lithotripsy for stone removal (left side), transurethral ureteroscopic holmium laser lithotripsy for stone removal (right side), and transurethral ureteral stent implantation (both sides) from 16:45 to 17:40, with ureters placed during the operation.At 19:33 on the (b)(6), the patient complained of unbearable pain in the urethra, so the doctor considered that the tubing was the cause of the pain and removed the urethra, which was found to be ruptured near the tip of the urethra.The patient complained of pain relief after the tubing was removed, and the surgeon closely monitored the patient's condition.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.This report references a us equivalent device.The us udi equivalent for this product number is used.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: Bardia® Foley Catheter Silicone Coated
• Common Device Name: Latex Silicone 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 ; +1(770)784-6100
• MDR Report Key: 25566058
• Report Number: 1018233-2026-03976
• Device Sequence Number: 9910897
• Product Code: KOD
• UDI-Device Identifier: 00801741095191
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K922431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 123616A
• Device Lot Number: MYJS1018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2026
• Supplement Date Received by Manufacturer: 09/19/2026
• Initial Report FDA Received Date: 06/19/2026
• Supplement Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/28/2024
• 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