BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXXIM MEDICAL

    MDR report key: 227852 · Received June 17, 1999

    Report

    Report Number
    MW1016551
    Event Type
    Malfunction
    Date Received
    June 17, 1999
    Date of Event
    April 30, 1999
    Report Date
    June 9, 1999
    Manufacturer
    MAXXIM MEDICAL, INC. CASE MGMT
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A SWAN GANZ CATHETER WAS REMOVED FROM THE INTRODUCER. AS THE SWAN WAS REMOVED AN "O" RING CAME WITH IT, HANGING FROM THE SWAN GANZ. NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXXIM MEDICAL TUOY BORST INTRODUCER TRAY 8F DYB MAXXIM MEDICAL, INC. CASE MGMT * *

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other