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

Catalog Number	119316M
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2025
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.The reported product number is unknown.The udi number for this product is not available.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.
Event or Problem Description
It was reported that the patient had foley catheter in place, was leaking requiring replacement.2nd foley leaking more than the first, again replaced.Additional foley in same size was opened.The balloon not inflating all the way around the catheter allowing for urine to flow outside of the catheter.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Correction: d, 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 the patient had foley catheter in place, was leaking requiring replacement.2nd foley leaking more than the first, again replaced.Additional foley in same size was opened.The balloon not inflating all the way around the catheter allowing for urine to flow outside of the catheter.
Additional Manufacturer Narrative
The reported event was inconclusive because this investigation did not result in any additional findings and the conditions of the sample did not allow any further evaluation.Received (3) photo samples.Visual evaluation of the returned three photo sample noted 1 opened, used silicone foley.Visual inspection of the first photo sample shows the catheter tip partially inflated with asymmetrical balloon.The second photo shows the labelling which came with the device.The third photo shows a zoomed in version of the labelling which came with the device.Functional testing was not possible based solely on these photos.Therefore, the reported event is considered inconclusive due to the inadequate sample condition.A review of the device history record could not be performed since no lot number was provided.Corrections made to tab(s) f and 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 the patient had foley catheter in place, was leaking requiring replacement.2nd foley leaking more than the first, again replaced.Additional foley in same size was opened.The balloon not inflating all the way around the catheter allowing for urine to flow outside of the catheter.

• Brand Name: BARDEX® LUBRI-SIL® I.C. ALL-SILICONE TEMP SENSING FOLEY CATHETER
• Common Device Name: ALL-SILICONE 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: 23247058
• Report Number: 1018233-2025-08920
• Device Sequence Number: 13340443
• Product Code: MJC
• UDI-Device Identifier: 00801741039911
• UDI-Public: (01)00801741039911
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/27/2026

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: 119316M
• 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: 09/30/2025
• Supplement Date Received by Manufacturer: 10/09/2025; 04/27/2026
• Initial Report FDA Received Date: 10/08/2025
• Supplement Report FDA Received Date: 10/09/2025; 05/04/2026
• 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