BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JELCO NEEDLE-PRO

    MDR report key: 1812108 · Received August 19, 2010

    Report

    Report Number
    1812108
    Event Type
    Malfunction
    Date Received
    August 19, 2010
    Date of Event
    August 13, 2010
    Report Date
    August 19, 2010
    Manufacturer
    SMITHS MEDICAL
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MEDICAL ASSISTANT (MA) WAS GIVING A MINOR PATIENT A VARICELLA VACCINATION INTO UPPER EXTREMITY AND NEEDLE BROKE OFF AT HUB WHERE THE WHITE PART CONNECTS NEEDLE TO BEVEL. MEDICATION SQUIRTED ALL OVER PATIENT, MA AND COUNTER. A NEW VACCINATION WAS DRAWN UP AND ADMINISTERED. THE STAFF HAVE BEEN HAVING ISSUES WITH THIS BRAND OF NEEDLES IN THAT THEY COME OUT OF THE PERSONS SUBCUTANEOUS TISSUE, BENT AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JELCO NEEDLE-PRO NEEDLE, HYPODERMIC, SINGLE LUMEN FMI SMITHS MEDICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR