MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 Bardex® I.C. Complete Care® Urine Meter Foley Tray

Catalog Number	903014A
Medical Device Problem Codes	Difficult to Remove (1528); Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2026
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.Initial reporter name: (b)(6) hospital.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 there was a difficulty in draining water from the foley catheter.

• Brand Name: Bardex® I.C. Complete Care® Urine Meter Foley Tray
• Common Device Name: Foley Tray
• 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: 24690114
• Report Number: 1018233-2026-02012
• Device Sequence Number: 9855225
• Product Code: MJC
• UDI-Device Identifier: 00801741019869
• UDI-Public: (01)00801741019869(17)270728(10)MYKS4585
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K910318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/11/2026

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: 903014A
• Device Lot Number: MYKS4585
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/01/2026
• 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: 03/24/2026
• Supplement Date Received by Manufacturer: 08/26/2026; 09/11/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 08/28/2026; 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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