MAUDE Adverse Event Report: C.R. Bard Inc. (Covington) -1018233 Bard® Urine Meter with Bag; Drain Bag

Catalog Number	153204
Medical Device Problem Codes	Complete Blockage (1094); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient received a urinary catheter during a primary cesarean section.Once in the pacu, the registered nurse attempted to drain the foley catheter and observed that the drainage tube was sealed shut to the foley bag, preventing drainage.The urinary catheter was removed, and a new catheter was placed.The rn retained the defective urinary catheter; however, the product packaging had been discarded at the time of insertion during the cesarean procedure, which occurred more than two hours earlier.
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: 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: Bard® Urine Meter with Bag
• Common Device Name: Drain Bag
• 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: 50483956
• Report Number: 1018233-2026-05613
• Device Sequence Number: 10173163
• Product Code: KNX
• UDI-Device Identifier: 00801741033117
• Combination Product (Y/N): N
• Initial Reporter State: NA
• Initial Reporter Country: US
• PMA/510(K) Number: K040504
• 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
• Report Date (Section B): 09/14/2026

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: 153204
• 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: 08/25/2026
• Supplement Date Received by Manufacturer: 09/14/2026
• Initial Report FDA Received Date: 08/27/2026
• Supplement Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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