BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VANISHPOINT

    MDR report key: 6033076 · Received October 17, 2016

    Report

    Report Number
    6033076
    Event Type
    Malfunction
    Date Received
    October 17, 2016
    Date of Event
    October 4, 2016
    Report Date
    October 7, 2016
    Manufacturer
    RETRACTABLE TECHNOLOGIES, INC
    Product Code
    MEG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE INJECTING INSULIN SUBCUTANEOUSLY, THE NEEDLE DID NOT RETRACT AS USUAL. RN "PUSHED" AS HARD AS SHE NORMALLY WOULD, BUT WHEN SHE REMOVED THE SYRINGE THE NEEDLE WAS STILL STICKING OUT AND SHE ACCIDENTALLY STUCK HER LEFT POINTER FINGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686183 VANISHPOINT SYRINGE, ANTISTICK MEG RETRACTABLE TECHNOLOGIES, INC M160302

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other