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

Catalog Number	0167V20S
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Codes	Micturition Urgency (1871); Abdominal Distention (2601)
Date of Event	04/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after surgery, the patient had a three-lumen foley catheter continuously irrigated with saline into the bladder.At 10:00 pm, the patient complained of a feeling of urinary urgency; the abdomen felt bloated on touch, and the bladder saline irrigation was not flowing well.Negative pressure aspiration was performed with a 50ml syringe, but no drainage fluid was obtained.At 11:20 pm, bedside ultrasound: the on-duty doctor adjusted the catheter and scanned again after injecting saline; a catheter-like echo was seen in the bladder, but no balloon-like echo was observed.The three-lumen catheter was removed, and the catheter balloon was found to be broken.
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: 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: 25538204
• Report Number: 1018233-2026-03928
• Device Sequence Number: 21171786
• Product Code: KOD
• UDI-Device Identifier: 00801741019227
• UDI-Public: (01)00801741019227(11)240611(17)281228(10)MYJQ5351
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 0167V20S
• Device Lot Number: MYJQ5351
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/15/2026
• 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: 06/11/2026
• Supplement Date Received by Manufacturer: 09/21/2026
• Initial Report FDA Received Date: 06/17/2026
• Supplement Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2024
• 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: Required Intervention
• Patient Sex: Unknown