MAUDE Adverse Event Report: C.R. Bard Inc. (Covington) -1018233 Bardex® Foley Catheter Silicone Coated; Latex Silicone Foley Catheter

Catalog Number	0167V22S
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient underwent a transurethral resection of the prostate at our hospital on (b)(6) 2026, at 11:25.At the end of the surgery, the nurse followed the doctor's instructions to insert a foley catheter.When the nurse tried to inflate the catheter balloon with a syringe after inserting it, she found that it wouldn't inflate.The catheter was immediately replaced, and the catheterization was successfully completed.
Additional Manufacturer Narrative
The initial reporter's city: (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: 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: Bardex® Foley Catheter Silicone Coated
• Common Device Name: Latex 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: 50181187
• Report Number: 1018233-2026-05269
• Device Sequence Number: 8216343
• Product Code: KOD
• UDI-Device Identifier: 00801741019234
• UDI-Public: (01)00801741019234(17)281028(10)MYHY2258
• 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): 08/17/2026

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: 0167V22S
• Device Lot Number: MYHY2258
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2026
• Supplement Date Received by Manufacturer: 08/17/2026
• Initial Report FDA Received Date: 08/07/2026
• Supplement Report FDA Received Date: 08/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/14/2024
• 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