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

Catalog Number	0119L18
Medical Device Problem Codes	Inaccurate Flow Rate (1249); Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when used in urology, the 3-way foley catheter balloon did not drain.Per follow up information received on 30dec2025, stated that it was unknown whether catheter did not drain urine or sterile water did not drain from the catheter.
Additional Manufacturer Narrative
Initial reporter name:(b)(6).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.
Additional Manufacturer Narrative
The reported event was confirmed manufacturing related.Based on the evaluation, it was observed that the irrigation eye was not properly punch.The catheter was able to be inflated and deflated without any issues.Water was able to flow through the drainage lumen and out from the drainage eye without obstruction.However, water was unable to be introduced through the irrigation funnel.Catheter was examined under microscope and observed that the irrigation eye was not properly punch.Hence, this complaint is confirmed manufacturing related.A potential root cause for this failure mode could be due to incorrect eye size caused by wrong die used.A review of the device labelling has been conducted for investigation purposed.A review of the lot file showed no rejects or rework associated with this issue.For the affected date code, the rejected units were recorded as in process scrap and will be disposed of after inspection.No non conformities or discrepancies were identified in any of the dhrs.Therefore, no additional action required at this time.Corrections: d, f, h.This report references a us equivalent device.The us udi equivalent for this product number is used.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.
Event or Problem Description
It was reported that when used in urology, the 3 way foley catheter balloon did not drain.Per follow up information received on 30dec2025, stated that it was unknown whether catheter did not drain urine or sterile water did not drain from the catheter.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER
• 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: 24029846
• Report Number: 1018233-2025-11640
• Device Sequence Number: 8859606
• Product Code: EZC
• UDI-Device Identifier: 00801741019067
• UDI-Public: (01)00801741019067(11)250725(17)300328(10)MYKS3302
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2026

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: 0119L18
• Device Lot Number: MYKS3302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2025
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2025
• 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