MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARDEX® LUBRICATH® CARSON MODEL FOLEY CATHETER COUDE TIP; LUBRICATH FOLEY CATHETER

Catalog Number	0168L16
Medical Device Problem Codes	Material Puncture/Hole (1504); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that since product was already used, customer checked the outside of the bag, but no cracks or other damage were found in the balloon of the foley catheter.It seems that it came out naturally after insertion.
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 since product was already used, customer checked the outside of the bag, but no cracks or other damage were found in the balloon of the foley catheter.It seems that it came out naturally after insertion.
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6) hospital, (b)(6).The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Correction: f, 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.
Additional Manufacturer Narrative
The reported event was unconfirmed.Inspected the exterior of catheter and did not find any evidence of a failure that would support the reported event.Sample has been evaluated and did not find any holes, rips or tears.Introduced water into the drainage eye and did not find any leakage from the distal end of the sample.Inflated balloon with air while submerged in water and there were no bubbles to indicate a leak.The shape of catheter balloon was meet the internal concentricity specification for this product is 70/30.Performed leak test on the seventh day, the balloon was fully inflated with no signs of leaking.Measured the shaft of the catheter and found the catheter was manufactured within the specification.Therefore, this complaint is unconfirmed since it was not contributed as per reported event.No root cause could be found because the reported event was unconfirmed.Per s03fa211 revision 28, as the reported event is unconfirmed, a labeling review is not required.A device history record review was not required as the investigation was unconfirmed.The investigation is concluded, and no additional action is required at this time.Corrections: d, h.Initial reporter facility name: # (b)(6).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 since product was already used, customer checked the outside of the bag, but no cracks or other damage were found in the balloon of the foley catheter.It seems that it came out naturally after insertion.

• Brand Name: BARDEX® LUBRICATH® CARSON MODEL FOLEY CATHETER COUDE TIP
• Common Device Name: LUBRICATH 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: 23270464
• Report Number: 1018233-2025-09011
• Device Sequence Number: 21206453
• Product Code: EZC
• UDI-Device Identifier: 00801741017827
• UDI-Public: (01)00801741017827(11)240118(17)280831(10)NGJN0898
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K910846
• 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,Followup
• Report Date (Section B): 12/19/2025

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: 0168L16
• Device Lot Number: NGJN0898
• 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: 10/06/2025
• Supplement Date Received by Manufacturer: 10/14/2025; 12/19/2025
• Initial Report FDA Received Date: 10/10/2025
• Supplement Report FDA Received Date: 10/15/2025; 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2024
• 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