MAUDE Adverse Event Report: C.R. Bard Inc. (Covington) -1018233 Bard® Urinary Drainage Bag with Anti-Reflux Chamber

Catalog Number	154002
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the customer had a bard medical 14fr foley tray system catheter (reference: (b)(4) was placed on the patient for intravesical chemotherapy.When the nurse went to instill the chemotherapy, the needle-free sampling port, where the equashield connector was to be attached, was noted to be missing or broken, preventing attachment of the equashield device for chemotherapy administration.The drainage bag and tubing were removed, and a new bag (medline add-a-cath) was attached to the catheter, which had the correct port.The customer stated that the same issue was observed in multiple kits from the same lot number on the same day.
Additional Manufacturer Narrative
Corrections made to tab(s) d, e, g.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.

• Brand Name: Bard® Urinary Drainage Bag with Anti-Reflux Chamber
• Common Device Name: Urinary Drainage 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 30014 ; +1(770)784-6100
• MDR Report Key: 50889830
• Report Number: 1018233-2026-06096
• Device Sequence Number: 14910157
• Product Code: KNX
• UDI-Device Identifier: 00801741034152
• UDI-Public: (01)00801741034152
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2026

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: 154002
• 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: 09/16/2026
• Supplement Date Received by Manufacturer: 09/23/2026
• Initial Report FDA Received Date: 09/24/2026
• Supplement Report FDA Received Date: 09/29/2026
• 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