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

Catalog Number	900016A
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The initial reporter's phone number: (b)(6).The initial reporter's facility name: (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.
Event or Problem Description
It was reported that during insertion, the catheter experienced that during balloon exchange and insertion into the patient the area near the funnel bulged after approximately 5 ml of water was injected, attempts to withdraw the water were unsuccessful and the syringe could not be moved, resulting in the funnel being cut to allow withdrawal of the water, with no water able to be injected thereafter, no kinking or bending observed other than bulging after injection, the lot number identified as mykq3348, and the troubleshooting procedure in the notice document was not attempted, also noted same lot has also been recalled, one unit was used by a patient, and three units remain unopened.(total: 4 units).

• Brand Name: Bardex® I.C. Complete Care® 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: 24443446
• Report Number: 1018233-2026-01204
• Device Sequence Number: 10307791
• Product Code: MJC
• UDI-Device Identifier: 00801741019371
• UDI-Public: (01)00801741019371(11)250528(17)270628(10)MYKQ3348
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K040658
• 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
• Report Date (Section B): 09/23/2026

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: 900016A
• Device Lot Number: MYKQ3348
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/27/2026
• 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: 02/17/2026
• Supplement Date Received by Manufacturer: 09/23/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2025
• 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: Required Intervention; Other
• Patient Sex: Unknown