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

Catalog Number	119316
Medical Device Problem Codes	Material Rupture (1546); Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2025
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.Initial reporter name:(b)(6).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 that there was a balloon rupture after inserting a urinary foley catheter, urine was found to be leaking out from the connection between the catheter and the balloon.As this was not a temporary occurrence, the catheter was removed and a new one was inserted, and the surgery proceeded without further issues.
Additional Manufacturer Narrative
The reported event is confirmed manufacturing related.This is addressed by capa 11092653.Visual evaluation of the returned sample noted one opened (without original packaging), used silicone foley catheter with syringe.Visual inspection noted no obvious observations.During testing, when inflating the catheter balloon with 10ml methylene blue solution (3 drops 1percent aq methylene blue per 100ml distilled water), lumen-to-lumen leakage was observed.This is out of specification per inspection procedure ip7603444, revision 0, which states, catheter leaks, valve leaks, balloon perforation, lumen to lumen, prematurely deflated and dislodged balloon are not allowed, and must inflate and deflate with the use of a syringe." the possible root causes for this failure, per capa 11092653, are funnel wall thickness to thin due to molding core pin shape or extruded tube diameter with variation causing leak in catheter funnel molding.Risk review, labeling review, and dhr review are not required as event has already been investigated per capa 11092653.Refer to capa 11092653 for further details.Correction: d,f,h 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 that there was a balloon rupture after inserting a urinary foley catheter, urine was found to be leaking out from the connection between the catheter and the balloon.As this was not a temporary occurrence, the catheter was removed and a new one was inserted, and the surgery proceeded without further issues.Per additional information received via ibc on 28ug2025, stated that the overview of the event was changed to urine leakage from balloon breakage.

• Brand Name: BARDEX® LUBRI-SIL® I.C. TEMPERATURE-SENSING ALL-SILICONE FOLEY CATHETER
• Common Device Name: TEMP SENSING 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: 22896623
• Report Number: 1018233-2025-07089
• Device Sequence Number: 8897002
• Product Code: MJC
• UDI-Device Identifier: 00801741039850
• UDI-Public: (01)00801741039850(11)240924(17)290922(10)NGJV3287
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K070582
• 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): 12/15/2025

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: 119316
• Device Lot Number: NGJV3287
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2024
• 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