BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASSURE ID: SAFETY PEN NEEDLE

    MDR report key: 8847785 · Received July 31, 2019

    Report

    Report Number
    MW5088578
    Event Type
    Injury
    Date Received
    July 31, 2019
    Date of Event
    July 9, 2019
    Report Date
    July 2, 2019
    Manufacturer
    ARKRAY FACTORY USA, INC.
    Product Code
    MEG
    UDI-DI
    08317275130
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NURSE ADMINISTERED INSULIN TO PT. NURSE THEN ATTEMPTED TO REMOVE NEEDLE FROM INSULIN PEN, AND PEN NEEDLE BROKE APART STICKING THE NURSE TWICE ON FINGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638398 ASSURE ID: SAFETY PEN NEEDLE SYRINGE, ANTISTICK MEG ARKRAY FACTORY USA, INC. 607081 08317275130

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR