BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5F STIFF MICRO-STICK

    MDR report key: 3953597 · Received July 3, 2014

    Report

    Report Number
    2518902-2014-00045
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 2, 2014
    Report Date
    July 3, 2014
    Manufacturer
    MEDCOMP
    Product Code
    DYB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS BEEN INITIATED. WE ARE CURRENTLY WAITING FOR THE RETURN OF THE DEVICE SAMPLE FOR EVALUATION. WHEN THE INVESTIGATION IS COMPLETE A FINAL REPORT WILL BE SUBMITTED.

    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 UNIT WITH NEEDLE AND THE WIRE WAS REMOVED-NO LOST PIECES. NO UNTOWARD PROBLEMS TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390494 5F STIFF MICRO-STICK INTRODUCER DYB MEDCOMP MR190511 ,BSP190

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention NEEDLE