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

Catalog Number	0168L18
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2025
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 the customer stated that they had a defective foley catheter.The registered nurse had inserted the catheter, went to inflate the balloon, and the fluid squirted out the catheter in the area between end of the catheter (inserted in patient) and the y-port.They took picture of the packing, and they do not have the actual catheter.Unfortunately, the catheter had to be removed and reinserted with a new one.
Event or Problem Description
It was reported that the customer stated that they had a defective foley catheter.The registered nurse had inserted the catheter, went to inflate the balloon, and the fluid squirted out the catheter in the area between end of the catheter (inserted in patient) and the y port.They took picture of the packing, and they do not have the actual catheter.Unfortunately, the catheter had to be removed and reinserted with a new one.
Additional Manufacturer Narrative
The reported event is inconclusive.Received (2) photo samples of the packaging label for a hydrogel coated latex foley catheter.Verified material number 0168l18 and lot number ngkn4117.The condition of the affected catheter could not be confirmed because only photos were provided for the investigation.Functional testing was not possible based solely on these photos.Therefore, the reported event is considered inconclusive due to the inadequate sample condition.The labeling is found to be adequate.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Based on the results of the investigation, no additional actions can be taken at this time.Correction: d, e, 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.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER COUDE TIP
• Common Device Name: LATEX 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: 22874307
• Report Number: 1018233-2025-06971
• Device Sequence Number: 5687812
• Product Code: EZC
• UDI-Device Identifier: 00801741017834
• UDI-Public: (01)00801741017834(11)250315(17)290228(10)NGKN4117
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• 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): 03/12/2026

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: 0168L18
• Device Lot Number: NGKN4117
• 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: 08/18/2025
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 03/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2025
• 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