MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARDEX® LUBRI-SIL® I.C. ALL-SILICONE COATED 5 CC FOLEY CATHETER

Catalog Number	1758SI16
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2025
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.All available udi information is being provided.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 in or department, inserted one of these foley catheters in a patient and could not get the balloon to inflate.They opened a 2nd tray and had the same issue with that tray.They did not keep any of the used catheters.They only have the outer packages, but they do not have the lot numbers on the outer packaging.Per customer follow up information received via email on 17nov2025, it was reported that they have the outer wrappers for the 2 foley trays, but unfortunately the staff did not retain the defective catheters.Lot number was not available.Two urinary catheter insertions were required.Removal and reinsertion of urinary catheter were performed.They were performed troubleshooting.Attempted to insert a foley and the balloon would not inflate.Foley removed.Opened another foley kit and while testing the balloon a leak was seen, and this balloon would also not inflate.Opened another foley kit, balloon tested and inflated appropriately.Foley inserted and then unable to draw urine from the port with syringe.
Event or Problem Description
It was reported that in or department, inserted one of these foley catheters in a patient and could not get the balloon to inflate.They opened a 2nd tray and had the same issue with that tray.They did not keep any of the used catheters.They only have the outer packages, but they do not have the lot numbers on the outer packaging.Per customer follow up information received via email on 17nov2025, it was reported that they have the outer wrappers for the 2 foley trays, but unfortunately the staff did not retain the defective catheters.Lot number was not available.Two urinary catheter insertions were required.Removal and reinsertion of urinary catheter were performed.They were performed troubleshooting.Attempted to insert a foley and the balloon would not inflate.Foley removed.Opened another foley kit and while testing the balloon a leak was seen, and this balloon would also not inflate.Opened another foley kit, balloon tested and inflated appropriately.Foley inserted and then unable to draw urine from the port with syringe.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A dhr could not be performed since no lot number was provided.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® I.C. ALL-SILICONE COATED 5 CC 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: 23639922
• Report Number: 1018233-2025-10523
• Device Sequence Number: 9841102
• Product Code: EZL
• UDI-Device Identifier: 00801741025228
• UDI-Public: (01)00801741025228
• Combination Product (Y/N): Y
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K040504
• 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): 04/20/2026

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: 1758SI16
• 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: 11/17/2025
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 04/21/2026
• 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 Age: 78 YR
• Patient Sex: Female
• Patient Weight: 80 KG
• Patient Race: White