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

Catalog Number	0167V24S
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Exposure to Body Fluids (1745); Discomfort (2330); Skin Inflammation/ Irritation (4545)
Date of Event	01/06/2026
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.Udi format updated with available product information per gudid.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 was bedridden for a long time and has an indwelling foley catheter.After the catheter was replaced on (b)(6) 2026, there was continuous urine leakage from the urethral opening.After reporting to the doctor, corresponding measures were taken, but the leakage problem could not be resolved.The patient's skin has been in prolonged contact with urine, resulting in skin damage in the sacrococcygeal area, causing emotional distress and anxiety for both the patient and their family.After the doctor reinserted a new catheter for the patient, the urine leakage no longer occurred.

• 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: 24422835
• Report Number: 1018233-2026-01173
• Device Sequence Number: 10577321
• Product Code: KOD
• UDI-Device Identifier: 00801741019241
• UDI-Public: (01)00801741019241(11)230621(17)280228(10)MYHR0350
• 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): 09/19/2026

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: 0167V24S
• Device Lot Number: MYHR0350
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/14/2026
• 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: 02/14/2026
• Supplement Date Received by Manufacturer: 09/19/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/21/2023
• 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