MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 Bardia® Foley Catheter Silicone Coated; Silicone Foley Catheter

Catalog Number	123516A
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.(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.
Event or Problem Description
It was reported that thirty minutes after foley catheter insertion, leakage was observed.Upon inspection, it was found that the catheter bifurcation was damaged.
Event or Problem Description
It was reported that thirty minutes after foley catheter insertion, leakage was observed.Upon inspection, it was found that the catheter bifurcation was damaged.
Additional Manufacturer Narrative
The reported event was confirmed, cause unknown.The reported failure was able to be reproduced.Based on the attached photo, a tear was observed at the catheter bifurcation area, resulting in water leakage.Further functional testing and comprehensive investigation could not be performed as only photographs were provided for evaluation.Therefore, the exact cause of the issue and the point at which it occurred could not be determined.A potential root cause for this failure could be over dipping caused stripping difficulty, torn funnels and premature deflators and also might be contributed by user-mishandling the product etc.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 nonconformities or discrepancies were identified in any of the dhrs.Corrections made to tab(s) f and h.Initial reporter phone: (b)(6).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.

• Brand Name: Bardia® Foley Catheter Silicone Coated
• Common Device Name: Silicone 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: 25352859
• Report Number: 1018233-2026-03528
• Device Sequence Number: 18753094
• Product Code: EZC
• UDI-Device Identifier: 00801741171680
• UDI-Public: (01)00801741171680(11)250922(17)300528(10)MYKV5880
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2026

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: 123516A
• Device Lot Number: MYKV5880
• Was Device Available for Evaluation?: No
• 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: 05/24/2026
• Supplement Date Received by Manufacturer: 09/19/2026
• Initial Report FDA Received Date: 06/01/2026
• Supplement Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/22/2025
• 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