BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VANISHPOINT

    MDR report key: 1855081 · Received September 29, 2010

    Report

    Report Number
    1855081
    Event Type
    Malfunction
    Date Received
    September 29, 2010
    Date of Event
    September 24, 2010
    Report Date
    September 29, 2010
    Manufacturer
    RETRACTABLE TECHNOLOGIES, INC.
    Product Code
    MEG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE RN ADMINISTERED THE FLU SHOT TO THE PATIENT. UPON WITHDRAWING THE SYRINGE, RN NOTICED THAT THE NEEDLE WAS NO LONGER ATTACHED TO THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VANISHPOINT SYRINGE, ANTISTICK, TUBERCULIN MEG RETRACTABLE TECHNOLOGIES, INC. * G091001

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR NO OTHER THERAPIES