BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLINK

    MDR report key: 1897195 · Received October 15, 2010

    Report

    Report Number
    1897195
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    October 12, 2010
    Report Date
    October 15, 2010
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SEVERAL COMPLAINTS RECEIVED FROM NURSING STAFF. WHILE ATTEMPTING TO PIERCE A 10 ML VIAL OF NORMAL SALINE WITH THE BD VIAL ACCESS CANNULA, THE CANNULA BENT TO A 90 DEGREE ANGLE. ONE INCIDENT RESULTED IN A CLEAN NEEDLE STICK TO THE OPERATOR.====================== MANUFACTURER RESPONSE FOR ACCESS CANNULA, BD VIAL ACCESS CANNULA======================REPRESENTATIVE WILL PICK UP THE DEVICE THE WEEK OF OCTOBER 17

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERLINK NEEDLE, HYPODERMIC, SINGLE LUMEN, VIAL ACCESS CANNULA FMI BECTON DICKINSON 303367 0057538

    Patients

    Seq Age Sex Outcome Treatment
    1 *