MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARDEX® LUBRI-SIL® ALL-SILICONE TEMP SENSING FOLEY CATHETER

Catalog Number	119216M
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Date of Event	03/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the medical intensive care unit that five different patients experienced leaking (pt 1, pt 2, pt 3, pt 4, pt 5) with silicone temperature sensing foley catheters between (b)(6) 2026.All affected devices were 16 fr foley catheters, number 1011818.There had been fewer reports of leaking since that time.The icu also reported previous issues with the wire raised out of the silicone material, which made the foley catheter rough and resulted in skin breakdown for patients.No medical intervention was reported.New foleys were inserted.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.Udi format updated with available product information per gudid.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.
Additional Manufacturer Narrative
The reported event was inconclusive because this investigation did not result in any additional findings and no sample was available for evaluation.The dhr review could not be performed without a lot number.Udi format updated with available product information per gudid.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 by the medical intensive care unit that five different patients experienced leaking with silicone temperature-sensing foley catheters between (b)(6) 2026.All affected devices were 16 fr foley catheters, lawson number (b)(4).There had been fewer reports of leaking since that time.The icu also reported previous issues with the wire raised out of the silicone material, which made the foley catheter rough and resulted in skin breakdown for patients.No medical intervention was reported.New foleys were inserted.

• Brand Name: BARDEX® LUBRI-SIL® ALL-SILICONE TEMP SENSING 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: 24718489
• Report Number: 1018233-2026-02078
• Device Sequence Number: 6121830
• Product Code: EZL
• UDI-Device Identifier: 00801741046308
• UDI-Public: (01)00801741046308
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K070582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2026

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: 119216M
• 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: 03/24/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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