MAUDE Adverse Event Report: C.R. Bard Inc. (Covington) -1018233 Bardex® Lubricath® Foley Catheter; Latex Foley Catheter

Catalog Number	0165L14
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on insertion of foley catheter normal procedure for bard tray and 10 ml inflation of ballon as per normal procedure.Same nurse visited 10 days later due to blocked catheter and on removal of catheter met with resistance after initial deflation with 10 ml syringe and further 10 ml removed therefore inflation balloon now had 20 ml in.Human error at time of insertion ruled out.Cannot quantify if human interference post insertion.Yellow card to rule out manufacturing problem i.E.Saline in inflation syringe.
Additional Manufacturer Narrative
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: 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
• Common Device Name: Latex 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: 50179361
• Report Number: 1018233-2026-05241
• Device Sequence Number: 8216767
• Product Code: EZC
• UDI-Device Identifier: 00801741017476
• UDI-Public: (01)00801741017476(11)250816(17)270926(10)NGKU2936
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/25/2026

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: 0165L14
• Device Lot Number: NGKU2936
• 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: 08/03/2026
• Supplement Date Received by Manufacturer: 08/26/2026; 09/25/2026
• Initial Report FDA Received Date: 08/07/2026
• Supplement Report FDA Received Date: 08/28/2026; 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/16/2025
• 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: Male