MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARDEX® I.C. FOLEY CATHETER

Catalog Number	0167SI22
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2025
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 they have a defective foley catheter, one of the 3 holes on the insertion tip was raised, and the fluid did not flow out.The whole lot was pulled, so they have a total of 8 to be returned.(material# 0167si22, lot# ngkr1988).
Event or Problem Description
It was reported that they have a defective foley catheter, one of the 3 holes on the insertion tip was raised, and the fluid did not flow out.The whole lot was pulled, so they have a total of 8 to be returned.(material# 0167si22, lot# ngkr1988).
Additional Manufacturer Narrative
The reported event was unconfirmed as the product meets specifications.5th catheter: visual inspection noted no external defects or other obvious observations.Inflated balloon with 10 ml of solution using the in-house luer lock syringe and the catheter rested with no leaks noted.Deflated balloon passively with no leaks or cuffing noted.Flushed drainage lumen with d.I.Water successfully with no blockage or defects found.6th catheter: visual inspection noted no external defects or other obvious observations.Inflated balloon with 10 ml of solution using the in-house luer lock syringe and the catheter rested with no leaks noted.Deflated balloon passively with no leaks or cuffing noted.Flushed drainage lumen with d.I.Water successfully with no blockage or defects found.7th catheter: visual inspection noted no external defects or other obvious observations.Inflated balloon with 10 ml of solution using the in-house luer lock syringe and the catheter rested with no leaks noted.Deflated balloon passively with no leaks or cuffing noted.Flushed drainage lumen with d.I.Water successfully with no blockage or defects found.8th catheter: visual inspection noted no external defects or other obvious observations.Inflated balloon with 10 ml of solution using the in-house luer lock syringe and the catheter rested with no leaks noted.Deflated balloon passively with no leaks or cuffing noted.Flushed drainage lumen with d.I.Water successfully with no blockage or defects found.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Corrections made to tab(s) d, 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® I.C. 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: 23821935
• Report Number: 1018233-2025-11230
• Device Sequence Number: 21348883
• Product Code: MJC
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K910318
• 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): 05/04/2026

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: 0167SI22
• Device Lot Number: NGKR1988
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2025
• Supplement Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2025
• 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