MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 Bardex® Lubricath® Foley Catheter Councill Model

Catalog Number	0196L16
Medical Device Problem Codes	Material Puncture/Hole (1504); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/24/2026
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that when the writer went in to assess the patient, no drainage was noted in the foley bag.At the start of the shift, a small amount of drainage had been observed in the tubing.The writer asked the patient if the bag had been emptied, and the patient stated that it had not.The foley tubing had been routed through the patient¿s pants, making it impossible to see whether it was secured in the leg strap.A bladder scan showed 800 ml.The patient reported being comfortable and did not feel an urge to void.When the patient removed their pants, the foley catheter was found to be out of place with the balloon deflated.No trauma was noted to the penis, and the patient stated they did not feel any pain or a ¿tug¿ and were unsure how it happened.The foley catheter was placed in a specimen bag and provided to the cne.

• Brand Name: Bardex® Lubricath® Foley Catheter Councill 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 ; +1(770)784-6100
• MDR Report Key: 24506147
• Report Number: 1018233-2026-01482
• Device Sequence Number: 18745860
• Product Code: EZC
• UDI-Device Identifier: 00801741017926
• UDI-Public: (01)00801741017926(11)251114(17)291031(10)NGKW0025
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K910846
• 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): 08/13/2026

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: 0196L16
• Device Lot Number: NGKW0025
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/26/2026
• 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: 02/27/2026
• Supplement Date Received by Manufacturer: 08/13/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 08/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2025
• 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: Other
• Patient Sex: Unknown