MAUDE Adverse Event Report: C. R. BARD, INC. BARD® SILASTIC® FOLEY CATHETER; CATHETER, RETENTION TYPE, BALLOON

Model Number	33618
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Bard silastic 18 and 20 french foley catheters - recurrence incidents of drainage issues associated with these catheters in post-radical prostatectomies patients.Cather stopped draining as intended.

• Brand Name: BARD® SILASTIC® FOLEY CATHETER
• Common Device Name: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd.; covington GA 30014
• MDR Report Key: 23014895
• Report Number: 23014895
• Device Sequence Number: 15839440
• Product Code: EZL
• UDI-Device Identifier: 00801741020070
• UDI-Public: (01)00801741020070(17)290531(10)
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/31/2025
• Report Date (Section F): 08/31/2025

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
• Device Model Number: 33618
• Device Catalogue Number: 33618
• Device Lot Number: NGJX5831
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 09/10/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/10/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Male
• Date Report Sent to FDA: 08/31/2025