BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUVEIN

    MDR report key: 6951515 · Received October 16, 2017

    Report

    Report Number
    6951515
    Event Type
    Malfunction
    Date Received
    October 16, 2017
    Date of Event
    September 21, 2017
    Report Date
    September 21, 2017
    Manufacturer
    ACCUVEIN INC.
    Product Code
    KZA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    IN THE PAST SOMEONE HAD STOLEN THE ACCUVEIN FROM THE ACCUVEIN CART SO WE BOUGHT A NEW ONE AND PLACED A SCREW ON IT TO KEEP THE ACCUVEIN IN PLACE. TODAY WE NOTICED THE SCREW WAS GONE. WE CONTACTED ACCUVEIN FOR A SECURITY SCREW AND THEY DO NOT OFFER ONE. IN MY OPINION THEY SHOULD OFFER THIS SCREW FOR THEIR EQUIPMENT AND NOT ONLY SHOULD THEY OFFER IT BUT IT SHOULD BE PROVIDED AS PART OF THE INITIAL PURCHASE. MANUFACTURER RESPONSE: FOR ACCUVEIN CART, ACCUVEIN (PER SITE REPORTER). THEY SAID JUST PUT A SCREW IN IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731854 ACCUVEIN DEVICE, VEIN LOCATION, LIQUID CRYSTAL KZA ACCUVEIN INC. HF470

    Patients

    Seq Age Sex Outcome Treatment
    1 NO