BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANTUS SOLO STAR ULTRA FINE NEEDLE

    MDR report key: 3140845 · Received May 24, 2013

    Report

    Report Number
    MW5030336
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Report Date
    May 24, 2013
    Manufacturer
    CANAMCARE
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    EMPLOYEE WAS ATTACHING A NEEDLE TO CUSTOMERS INSULIN PEN. NEEDLE WAS DEFECTIVE - HAD AN ADD'L NEEDLE THAT WAS STICKING OUT OF THE SIDE OF THE NEEDLE CAP. THIS ADD'L NEEDLE PRICKED EMPLOYEES RIGHT THUMB. NEEDLE WAS CLEAN. MODEL #: RELI ON SHORT PIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231097 LANTUS SOLO STAR ULTRA FINE NEEDLE INSULIN NEEDLE NBW CANAMCARE 12115001

    Patients

    Seq Age Sex Outcome Treatment
    1