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

Catalog Number	0167V20S
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	06/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on june 9, the patient underwent transurethral cystoscopic laser lithotripsy and partial plasma resection of the prostate under general anesthesia for bladder stones and prostatic hyperplasia.Following standard surgical protocol, a no.20 bard indwelling urinary foley catheter was inserted.The procedure was performed correctly: patient positioning and insertion technique were accurate, the insertion depth met standards, and the balloon was properly inflated for fixation.Immediately after insertion, the surgeon attempted to inject fluid into the catheter's inflation port but encountered resistance.Despite repeated adjustments to the catheter position, squeezing of the drainage tube, and efforts to rule out factors such as tube kinking, compression, twisting, blood clot obstruction, or urethral spasms, the issue persisted, suggesting an internal obstruction or narrowing of the catheter lumen.The catheter was promptly replaced; the new catheter provided unobstructed drainage, and the surgery proceeded as planned.This incident prolonged the operative time and increased the workload for the medical team; furthermore, the repeated catheterization caused injury to the patient's urethral mucosa, resulted in the waste of medical supplies, and increased the patient's hospitalization costs.
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: Bardex® 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 ; +1(770)784-6100
• MDR Report Key: 25623682
• Report Number: 1018233-2026-04088
• Device Sequence Number: 21381126
• Product Code: KOD
• UDI-Device Identifier: 00801741019227
• UDI-Public: (01)00801741019227(11)241123(17)290828(10)MYJX5885
• 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): 09/21/2026

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: 0167V20S
• Device Lot Number: MYJX5885
• 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: 06/18/2026
• Supplement Date Received by Manufacturer: 09/21/2026
• Initial Report FDA Received Date: 06/25/2026
• Supplement Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/23/2024
• 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