MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARDIA® FOLEY CATHETER SILICONE COATED

Catalog Number	123516A
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2026
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.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.
Event or Problem Description
It was reported that on march 17, 2026, at 10:35, the patient underwent a left flexible ureteroscopy and lithotripsy (fursl) procedure with ureteral stent placement under general anesthesia.Upon completion of the surgery, the patient returned to the ward and received intravenous fluid therapy, bedside cardiac monitoring, and oxygen support as per physician's orders; the indwelling urinary catheter was securely fixed.On march 20, at 12:43, the patient reported that their trousers felt damp; upon assisting the patient in changing their trousers, it was discovered that the urinary catheter had dislodged.Examination revealed that the catheter balloon had ruptured, although the balloon wall itself remained intact.The attending physician was immediately notified; the indwelling catheterization was discontinued, and the patient was instructed to increase their fluid intake.At 13:15, the patient successfully voided spontaneously, and the adverse event was resolved.

• Brand Name: BARDIA® FOLEY CATHETER SILICONE COATED
• 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: 24810967
• Report Number: 1018233-2026-02287
• Device Sequence Number: 16129152
• Product Code: EZC
• UDI-Device Identifier: 00801741095092
• UDI-Public: (01)00801741095092(11)230818(17)280428(10)MYHS1328
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K910846
• 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): 05/21/2026

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: 123516A
• Device Lot Number: MYHS1328
• 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: 04/02/2026
• Supplement Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/18/2023
• 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