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	08/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that day 3 of placement, foley catheter was inserted on (b)(6).Naturally removed around 7:00 pm on (b)(6).The balloon was damaged.It leaked from the balloon.
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6).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: 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 day 3 of placement, foley catheter was inserted on august 1st.Naturally removed around 7:00 pm on august 3rd.The balloon was damaged.It leaked from the balloon.
Additional Manufacturer Narrative
The initial reporter's facility name: (b)(6).The reported event has been confirmed and is being investigated by capas 12866756 & 12474528.Received 1 all silicone foley catheter with syringe.Verified material number 119316 and manufacturing lot number ngju0789.Visual inspection noted the catheter balloon had ruptured (measuring 0.3060).Further inspection noted the balloon had no missing pieces.This is out of specification 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." risk review, labeling review, and dhr review are not required as the event is being investigated per capas 12866756 & 12474528.Corrections: d, e, f, h.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: 23266504
• Report Number: 1018233-2025-08997
• Device Sequence Number: 5218192
• Product Code: MJC
• UDI-Device Identifier: 00801741039850
• UDI-Public: (01)00801741039850(11)290716(17)290716(10)NGJU0789
• 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): 03/02/2026

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: NGJU0789
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2025
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 10/10/2025
• Supplement Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2024
• 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