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

Catalog Number	0167L20
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter name: (b)(6) hospital.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.
Event or Problem Description
It was reported that while the patient was using the device.Fluid leakage was observed from the foley catheter shaft section during patient use, prompting discontinuation of use.Multiple scratches were noted on the shaft section, and it was replaced with a new one.
Event or Problem Description
It was reported that while the patient was using the device, fluid leakage was observed from the foley catheter shaft section during patient use, prompting discontinuation of use.Multiple scratches were noted on the shaft section, and it was replaced with a new one.There were about three scratches on the shaft.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.The product had caused the reported failure.The sample was evaluated, and a tear was observed on the catheter shaft.The inflation lumen was inflated, and water leakage was noted at the tear location.Visual inspection indicated that the tear exhibited a rough appearance, consistent with damage caused by contact with a sharp object or the application of external force.However, the exact cause of how and when problem occurred could not be determine.A potential root cause for this failure mode could be due to operator error when doing catheter inspection cause failed to detect cosmetic defect.The labeling is found to be adequate.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, g, 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.

• 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: 23478643
• Report Number: 1018233-2025-09940
• Device Sequence Number: 13318898
• Product Code: KOD
• UDI-Device Identifier: 00801741018961
• UDI-Public: (01)00801741018961(11)240219(17)281028(10)MYHY3999
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K922431
• 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,Followup,Followup
• Report Date (Section B): 07/22/2026

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: 0167L20
• Device Lot Number: MYHY3999
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/16/2026
• 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: 10/30/2025
• Supplement Date Received by Manufacturer: 05/12/2026; 06/17/2026; 07/22/2026
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 05/20/2026; 06/29/2026; 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2024
• 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