BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5F MICROSTICK INTRODUCER SET

    MDR report key: 3870186 · Received June 5, 2014

    Report

    Report Number
    MW5036534
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 4, 2014
    Manufacturer
    MEDCOMP
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE ACCESSING VEIN, DIFFICULTY REMOVING WIRE, WHEN PULLED BACK THE WIRE STRETCHED AND UNRAVELED. THE WIRE WAS THEN PULLED OUT AS A UNIT WITH NEEDLE AND THE WIRE WAS REMOVED (NO LOST PIECES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329435 5F MICROSTICK INTRODUCER SET DYB MEDCOMP MR190511 MBSP 190

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR