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

Catalog Number	165814
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while inflating foley balloon on insertion, saline noted to be leaking through a hole near the y junction.Unable to inflate balloon at tip of catheter as a result of the leak, and foley had to be removed.
Additional Manufacturer Narrative
The complete initial reporter's 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: sections 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 while inflating foley balloon on insertion, saline noted to be leaking through a hole near the y junction.Unable to inflate balloon at tip of catheter as a result of the leak, and foley had to be removed.
Additional Manufacturer Narrative
The initial reporter's facility name: (b)(6).The reported event was inconclusive because this investigation did not result in any additional findings and no sample was available for evaluation.The reported event is addressed within the labeling, and it states: - visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfection or surface deterioration is observed, do not use.A dhr could not be performed since no lot number was provided.No additional actions can be taken at this time.Corrections: f, h udi format updated with available product information per gudid.H11: sections 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® ALL-SILICONE 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: 23735399
• Report Number: 1018233-2025-10868
• Device Sequence Number: 10631620
• Product Code: GBM
• UDI-Device Identifier: 00801741029745
• UDI-Public: (01)00801741029745
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K760093
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2026

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: 165814
• 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: 11/28/2025
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 02/05/2026
• 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: 82 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White