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

Catalog Number	0167V18S
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Codes	Pain (1994); Genital Bleeding (4507)
Date of Event	02/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).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) 2026 at 20:00, during use, the single-use sterile urinary catheter (lot no.Myhw0894, 18fr) malfunctioned as the balloon failed to inflate when the prescribed amount of sterile saline was injected into the urinary tubing bladder for fixation, and leakage of the bladder balloon was confirmed preventing completion of fixation; the malfunctioning catheter was slowly withdrawn to avoid secondary injury, during which a small amount of fresh bleeding was observed at the patient¿s urethra and the patient reported obvious urethral pain, after which the catheter was immediately replaced with a new device and the indwelling catheterization procedure was completed according to the doctor¿s orders with subsequent bladder irrigation and proper fixation of the urethra and drainage bag.

• 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: 24571677
• Report Number: 1018233-2026-01645
• Device Sequence Number: 18234057
• Product Code: KOD
• UDI-Device Identifier: 00801741019210
• UDI-Public: (01)00801741019210(11)231027(17)280628(10)MYHW0894
• 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): 07/30/2026

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: 0167V18S
• Device Lot Number: MYHW0894
• 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: 03/09/2026
• Supplement Date Received by Manufacturer: 07/29/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 07/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/27/2023
• 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