MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARDEX® LUBRICATH® FOLEY CATHETER HOTTER MODEL

Catalog Number	6003L22
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by urology over the previous four months that this latex foley catheter was not functioning correctly.The dr.Had two patients in pacu whose catheters failed (unable to drain their bladder) (dr.Pt 2), and the dr.Had three patients with the same issue (dr pt 1, dr pt 2, dr pt 3).Today, they first tested this catheter (in the picture) on the back table to see if both openings were patent; one was patent, but the second (the lower port on the foley) was not.Then connected it to the anesthesia air insufflator to see if it was simply stuck, but it failed again.The dr.And customer agreed to open another catheter from the same lot to determine whether there was a trend, and that catheter worked.However, before the patient was ready to leave the room, the flow stopped again.A small piece of tissue from the turp was found in it, but since the dr.Was already concerned about the reliability of this catheter and changed it to a different one.The 22f 3way coude foley had been receiving multiple complaints from both drs.Today, the dr.Reported another issue.The patient in pacu had not been having adequate output or good cbi following aquablation.The dr.Removed the 22f coude, assuming it was clotted off.Unfortunately, it turned out to be another defective 22f 3way coude rather than a clot.As a result, the patient experienced additional pain while a different type of foley catheter had to be inserted while they were awake and uncomfortable.Customer checked to see whether this could have been tied to a single defective lot, but the urology cart contained multiple lot numbers.
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.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER HOTTER MODEL
• Common Device Name: FOLEY 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 ; 7707846100
• MDR Report Key: 24456401
• Report Number: 1018233-2026-01280
• Device Sequence Number: 9968796
• Product Code: KOD
• UDI-Device Identifier: 00801741018886
• UDI-Public: (01)00801741018886(17)280731(10)NGKW0683
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K922431
• 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
• Report Date (Section B): 02/25/2026

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: 6003L22
• Device Lot Number: NGKW0683
• 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: 02/12/2026
• Initial Report FDA Received Date: 02/26/2026
• 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