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

Catalog Number	123616A
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Pain (1994); Skin Discoloration (2074); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2025, the patient underwent transurethral right ureteroscopy with stent placement for right renal calculi complicated by hydronephrosis and infection.The procedure commenced at 11:07 and concluded at 14:09, with the patient returning to the ward with the catheter in place.At 14:52, the patient reported urethral orifice pain and urinary leakage.Nursing assessment revealed no significant displacement of the external catheter segment, with reduced urine volume in the collection bag.Gentle traction of the catheter confirmed balloon rupture.The urethral orifice mucosa appeared erythematous with minor bleeding, indicating potential infection risk.Subsequently, the patient resumed spontaneous urination without requiring re-catheterization.No lubricant was used.This represents an isolated incident.
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 (b)(6) 2025, the patient underwent transurethral right ureteroscopy with stent placement for right renal calculi complicated by hydronephrosis and infection.The procedure commenced at 11:07 and concluded at 14:09, with the patient returning to the ward with the catheter in place.At 14:52, the patient reported urethral orifice pain and urinary leakage.Nursing assessment revealed no significant displacement of the external catheter segment, with reduced urine volume in the collection bag.Gentle traction of the catheter confirmed balloon rupture.The urethral orifice mucosa appeared erythematous with minor bleeding, indicating potential infection risk.Subsequently, the patient resumed spontaneous urination without requiring re-catheterization.No lubricant was used.This represents an isolated incident.
Additional Manufacturer Narrative
The reported event was confirmed ¿ cause unknown.Based on the attached photos, it was observed that the balloon burst.The potential root cause of this failure mode 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 conditions that would have contributed to the reported issue.Therefore, no additional action required at this time.Corrections: d, e, h.This report references a us equivalent device.The us udi equivalent for this product number is used.H11: sections 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: 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: 23441360
• Report Number: 1018233-2025-09782
• Device Sequence Number: 4940992
• Product Code: KOD
• UDI-Device Identifier: 00801741095191
• UDI-Public: (01)00801741095191(11)240123(17)280928(10)MYHZ1681
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2026

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: 123616A
• Device Lot Number: MYHZ1681
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2025
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2024
• 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