BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® ALL- SILICONE FOLEY CATHETER TRAY

    MDR report key: 21917788 · Received April 28, 2025

    Report

    Report Number
    21917788
    Event Type
    Malfunction
    Date Received
    April 28, 2025
    Date of Event
    March 19, 2025
    Report Date
    April 23, 2025
    Manufacturer
    C. R. BARD, INC.
    Product Code
    EZL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SURESTEP FOLEY TRAY SYSTEM 16 FR W/ DRAINAGE BAG REF # A897516 WAS LEAKING AROUND THE GREEN EXIT TUBE FROM THE DRAINAGE BAG AFTER INSERTION. SEEMS TO BE A DEFECTIVE BAG. NO HARM TO PT, DRAIN BAG SWITCHED TO LEG BAG. MANUFACTURER RESPONSE FOR CATHETER, RETENTION TYPE, BALLOON, SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® ALL- SILICONE FOLEY CATHETER TRAY (PER SITE REPORTER). PRODUCT FAILURE WAS EMAILED TO BARD/BD ON [REDACTED]. THE EMAIL WAS ACKNOWLEDGED AND GIVEN CASE # [REDACTED]. THERE HAS BEEN NO OTHER COMMUNICATION PROVIDED FROM BARD/BD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1237405 SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® ALL- SILICONE FOLEY CATHETER TRAY CATHETER, RETENTION TYPE, BALLOON EZL C. R. BARD, INC. A897516 NGJW3316

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown