BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANTUS SOLO STAR ULTRA FINE NEEDLE

    MDR report key: 3231298 · Received July 11, 2013

    Report

    Report Number
    MW5030896
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Report Date
    July 11, 2013
    Manufacturer
    CANAMCARE
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    EMPLOYEE WAS ATTACHING A NEEDLE TO CUSTOMER'S INSULIN PEN. NEEDLE WAS DEFECTIVE - HAD AN ADDITIONAL NEEDLE THAT WAS STICKING OUT OF THE SIDE OF THE NEEDLE CAP. NO NEEDLE STICK. MANUFACTURER NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321425 LANTUS SOLO STAR ULTRA FINE NEEDLE INSULIN PEN NEEDLE FMI CANAMCARE RELI ON SHORT PIN 121043-04

    Patients

    Seq Age Sex Outcome Treatment
    1