BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUCTION CATHETER KIT

    MDR report key: 12810 · Received April 19, 1994

    Report

    Report Number
    MW1001644
    Event Type
    Malfunction
    Date Received
    April 19, 1994
    Report Date
    April 15, 1994
    Manufacturer
    SUPERIOR HEALTHCARE GROUP, INC.
    Product Code
    BSY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THREE DIFFERENT PROBLEMS HAVE BEEN REPORTED WITH THIS PRODUCT: 1. THE CATHETER IS TOO SOFT AND FLEXIBLE MAKING IT HARD TO PUT DOWN A PT'S THROAT. 2. SPUTUM WENT THROUGH THE TRAP SYSTEM INTO THE SUCTION MACHINE CONTAINER. 3. THE CONTAINER FOR HOLDING THE SUCTION SOLUTION LEAKED ON TO THE FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUCTION CATHETER KIT BSY SUPERIOR HEALTHCARE GROUP, INC. 4032A

    Patients

    Seq Age Sex Outcome Treatment
    1 *