BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICHOICE URETHRAL CATHETERIZATION TRAY

    MDR report key: 22622802 · Received July 28, 2025

    Report

    Report Number
    22622802
    Event Type
    Malfunction
    Date Received
    July 28, 2025
    Date of Event
    June 25, 2025
    Report Date
    June 30, 2025
    Manufacturer
    OWENS & MINOR DISTRIBUTION, INC.
    Product Code
    FCM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    A PATIENT IN PACU [POST ANESTHESIA RECOVERY UNIT] WAS STRAIGHT CATHED WITH A 14FR MEDI CHOICE CATHETER WITH 2 NURSES. AFTER THE STRAIGHT CATH, URINE WAS FOUND TO BE LEAKING THROUGH A CRACK IN THE CORNER OF THE BASIN TRAY. THIS WRITER IS UNSURE IF THE BASIN TRAY WAS CRACKED BEFORE OPENING, THEREFORE AFFECTING STERILITY OF THE ITEMS INSIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1100056 MEDICHOICE URETHRAL CATHETERIZATION TRAY TRAY, CATHETERIZATION, STERILE URETHRAL, WITH OR WITHOUT CATHETER (KIT) FCM OWENS & MINOR DISTRIBUTION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown