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

Catalog Number	119316
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the customer has recently experienced another incident involving a foley catheter balloon defect during surgery.After the procedure, the surgeon noted that the foley catheter had fallen out.Upon inspection, it was found that the balloon had ruptured, leading to deflation and dislodgement of the catheter.A new foley catheter was inserted without further complication.Per customer follow up information received via attachment on 25nov2025, it was reported that the foley fell out on floor, so they did not have to troubleshoot.Foley was placed by surgeon at start of case, after case was completed, drapes removed, the foley was noted to have been dislodged and fell on to the floor.The foley balloon had broken and did not appear to have any fragments -all rubber was still intact.Surgeon only used 10ml of the sterile water from the syringe provided in the foley kit.No patient impact and medical intervention was reported.Foley was replaced.
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.
Event or Problem Description
It was reported that the customer has recently experienced another incident involving a foley catheter balloon defect during surgery.After the procedure, the surgeon noted that the foley catheter had fallen out.Upon inspection, it was found that the balloon had ruptured, leading to deflation and dislodgement of the catheter.A new foley catheter was inserted without further complication.Per customer follow up information received via attachment on 25nov2025, it was reported that the foley fell out on floor, so they did not have to troubleshoot.Foley was placed by surgeon at start of case, after case was completed, drapes removed, the foley was noted to have been dislodged and fell on to the floor.The foley balloon had broken and did not appear to have any fragments -all rubber was still intact.Surgeon only used 10ml of the sterile water from the syringe provided in the foley kit.No patient impact and medical intervention was reported.Foley was replaced.
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 reported event is addressed within the labeling as it states, warnings: do not use ointments or lubricants having a petrolatum base.They will damage the catheter and may cause the balloon to burst.Inflate catheter balloon using entire 10cc of sterile water provided in the prefilled syringe.Note: use of less than 10cc can result in asymmetrically inflated balloon.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.No additional actions can be taken at this time.Correction: d 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.

• Brand Name: BARDEX® LUBRI-SIL® I.C. TEMPERATURE-SENSING ALL-SILICONE 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: 23717138
• Report Number: 1018233-2025-10766
• Device Sequence Number: 21397414
• Product Code: MJC
• UDI-Device Identifier: 00801741039850
• UDI-Public: (01)00801741039850(11)250302(17)270531(10)NGJZ0374
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 01/14/2026

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: 119316
• Device Lot Number: NGJZ0374
• 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: 11/25/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/02/2025
• 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