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

Catalog Number	123616A
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Distress (2329); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/28/2026
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that, on (b)(6) 2026, at 12:20 pm, the patient underwent vaginal anterior and posterior wall repair, repair of an old perineal laceration, and urethral suspension under general anesthesia at (b)(6) hospital.During the procedure, the physician placed a 16-gauge urinary foley catheter according to standard operating procedures and inflated the balloon with 10 ml of saline solution.The catheter placement was completed without incident.On (b)(6) 2026, at 9:35 am, during catheter removal in the ward, the balloon fluid could not be completely drained, preventing catheter extraction.Subsequent actions included: requesting consultation from urology and ultrasound departments; cutting the catheter in half; preparing for transurethral bladder foreign body removal under general anesthesia after all attempts failed.The catheter spontaneously dislodged around 15:30.This incident caused significant psychological distress and trauma to the patient, who was subsequently comforted.

• Brand Name: Bardia® 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: 24595117
• Report Number: 1018233-2026-01728
• Device Sequence Number: 8689025
• Product Code: KOD
• UDI-Device Identifier: 00801741095191
• UDI-Public: (01)00801741095191(11)240726(17)280329(10)MYJS1018
• 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): 08/27/2026

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: 123616A
• Device Lot Number: MYJS1018
• 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: 03/10/2026
• Supplement Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 08/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/26/2024
• 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; Required Intervention
• Patient Sex: Unknown