MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 Bard® Urethral Catheter

Catalog Number	120612
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2026
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 end-user inserted intermittent latex catheter into urethra to bladder and proceeded to empty bladder into the container.During the process, the patient noticed that their thigh was getting wet.Upon examination a small hole was noted next to the knob (bump) on the hub.When the bladder was empty, the catheter tip syringe was placed into hub and thumb was used to cover the hold and bcg installed.The patient denied getting wet after the first incident.No sample was kept; however, pictures of incident are available.

• Brand Name: Bard® Urethral Catheter
• Common Device Name: Urethral 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: 24829669
• Report Number: 1018233-2026-02344
• Device Sequence Number: 9222533
• Product Code: KOD
• UDI-Device Identifier: 00801741029950
• UDI-Public: (01)00801741029950(11)250324(17)291128(10)MYKP4106
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/20/2026

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: Lay User/Patient
• Device Catalogue Number: 120612
• Device Lot Number: MYKP4106
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/10/2026
• 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: 04/01/2026
• Supplement Date Received by Manufacturer: 08/11/2026; Not provided
• Initial Report FDA Received Date: 04/09/2026
• Supplement Report FDA Received Date: 08/12/2026; 08/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2025
• 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: Male
• Patient Race: White