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

Catalog Number	0167V16S
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Hematuria (2558)
Date of Event	12/13/2025
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; the patient entered the operating room at 09:00 on (b)(6) 2025.Under general anesthesia with a laryngeal mask airway in place, a transurethral left ureteroscopy laser lithotripsy and stone removal procedure was performed, followed by ureteral stent placement.The patient returned to the ward at 12:35.A double-lumen no.14 urinary catheter was placed intraoperatively and secured firmly for urine drainage.On (b)(6) 2025, at 09:00, the catheter was removed as ordered.Pale red urine was aspirated from the balloon during catheter extraction.The catheter was subsequently removed, revealing a clean-cut rupture of the balloon with neat edges.No medical intervention was reported.
Event or Problem Description
It was reported that, the patient entered the operating room at 09:00 on (b)(6) 2025.Under general anesthesia with a laryngeal mask airway in place, a transurethral left ureteroscopy laser lithotripsy and stone removal procedure was performed, followed by ureteral stent placement.The patient returned to the ward at 12:35.A double-lumen no.14 urinary catheter was placed intraoperatively and secured firmly for urine drainage.On (b)(6) 2025, at 09:00, the catheter was removed as ordered.Pale red urine was aspirated from the balloon during catheter extraction.The catheter was subsequently removed, revealing a clean-cut rupture of the balloon with neat edges.No medical intervention was reported.
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 user related (example: contact with sharp object)/ exposure to petrolatum based products/ mechanical failure/operator error).The labeling and instructions for use were found to be adequate.A review of the device history record did not show any problems or condition that would have contributed to the reported issue.Therefore, no additional action required at this time.Correction: d.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: BARDEX® FOLEY CATHETER SILICONE COATED
• Common Device Name: 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 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 24032134
• Report Number: 1018233-2025-11686
• Device Sequence Number: 15738237
• Product Code: KOD
• UDI-Device Identifier: 00801741019203
• UDI-Public: (01)00801741019203(11)241012(17)290528(10)MYJW1097
• 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): 01/30/2026

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: 0167V16S
• Device Lot Number: MYJW1097
• 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: 12/30/2025
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/12/2024
• 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