BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5F STIFF MICRO STICK

    MDR report key: 3814913 · Received May 2, 2014

    Report

    Report Number
    2518902-2014-00031
    Event Type
    Injury
    Date Received
    May 2, 2014
    Date of Event
    February 28, 2014
    Report Date
    May 1, 2014
    Manufacturer
    MEDCOMP
    Product Code
    DQX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE INCIDENT WAS NOT RETURNED FOR EVAL. W/O AN EVAL OF THE DEVICE INVOLVED, WE ARE UNABLE TO DETERMINE THE CAUSE OR FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    DURING INITIAL ACCESS OF ARTERY USING A MICRO PUNCTURE NEEDLE AND WIRE SET, THE TIP OF WIRE WAS SHAVED OFF AND LEFT IN PT. USING ANOTHER PRODUCT AND COMPANY EQUIVALENT THE SAME EVENT HAPPENED AND A SECOND TIP WAS SHAVED OFF AND LEFT IN PT. SURGICALLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265479 5F STIFF MICRO STICK GUIDEWIRE DQX MEDCOMP MR190511 MBSL250

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention