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

Catalog Number	73022L
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2025
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.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 customer received some faulty catheters.It was a 3-way catheter, and the end that was connected to the urine bag leaked urine, distal to the end hole where the user inserted the bag.
Event or Problem Description
It was reported that customer received some faulty catheters.It was a 3-way catheter, and the end that was connected to the urine bag leaked urine, distal to the end hole where the user inserted the bag.Per additional information received via email on 16sep2025, it was reported that the patient had surgery, usually a prostate surgery and had the catheter inserted at the end of the surgery.When the patient arrived in recovery the nurses noticed the catheter leaking just at the "y" junction, not at the balloon port, and not the main port but at the port for irrigation, they alerted the surgeon and then had to replace the catheter in the recovery room.There was no way to trouble shoot a leaking catheter, catheters had to be replaced in the recovery room.
Additional Manufacturer Narrative
The reported event was unconfirmed.Received 1 all silicone foley catheter with packaging.Verified material number 73022l, batch number ngkp3884 and manufacturing lot number ngju2497.Visual inspection noted no obvious observations.Urine lumen filled with water.No leakage present.Catheter filled with 35ml mbs using in-house syringe.Inflated with no difficulty.No leakage present.35ml deflated within (b)(6).The event was unconfirmed.Risk, labelling, and dhr review are not required as the reported event is unconfirmed.No additional actions can be taken at this time.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.

• Brand Name: BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER
• Common Device Name: SILICONE 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: 22714572
• Report Number: 1018233-2025-06479
• Device Sequence Number: 9611820
• Product Code: EZL
• UDI-Device Identifier: 00801741034329
• UDI-Public: (01)00801741034329(11)250308(17)290531(10)NGKP3884
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K070558
• 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): 01/22/2026

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: 73022L
• Device Lot Number: NGKP3884
• 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: 08/01/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 08/05/2025
• Supplement Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2025
• 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