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

Catalog Number	0165L12
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during pretesting a hole appeared in the foley catheter tube containing the fixative water, caused water to leak.There was a pinhole.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Initial reporter name: (b)(6).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.The product had caused the reported failure.Sample evaluation observed a tear at the inflation funnel area of the catheter.Sample was inflated with water and observed water leaking from the tear area.Tear was examined under microscope and noted to be rough.The tear looks like it was caused from outside.A review of the manufacturing process indicates that the process can produce of this type of defect.Based on the sample returned, it is confirmed as manufacturing related issue.Further investigation was documented under capa#13626172.A potential root cause for this failure mode could be failed to detect leakage related defect due to automated leak tester malfunction that can caused premature deflation on leakers.The labeling and instructions for use were found to be adequate.A review of the manufacturing process indicates that the process is capable of producing of this type of defect.However, current in-process controls per pfmea are adequate to identify the defect or verify the product integrity.Correction: d,f,h.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 during pretesting a hole appeared in the foley catheter tube containing the fixative water, caused water to leak.There was a pinhole.

• 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: 23290262
• Report Number: 1018233-2025-09113
• Device Sequence Number: 15959621
• Product Code: EZC
• UDI-Device Identifier: 00801741017469
• UDI-Public: (01)00801741017469(11)250515(17)270628(10)MYKP6642
• 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): 01/20/2026

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: 0165L12
• Device Lot Number: MYKP6642
• 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: 10/08/2025
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2025
• 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