BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VANISHPOINT INSULIN SYRINGE

    MDR report key: 7929846 · Received October 2, 2018

    Report

    Report Number
    MW5080293
    Event Type
    Malfunction
    Date Received
    October 2, 2018
    Date of Event
    September 24, 2018
    Report Date
    September 24, 2018
    Manufacturer
    RETRACTABLE TECHNOLOGIES, INC.
    Product Code
    MEG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    INFECTION CONTROL WAS NOTIFIED THAT THERE WERE PROBLEMS WITH VANISHPOINT INSULIN SYRINGE 1ML LOT # F180109. ON FIVE DIFFERENT OCCASIONS, DIFFERENT RNS, HAD DIFFICULTY DRAWING UP INSULIN. THE PLUNGER WOULD MOVE BACK AND FORTH, HOWEVER ONCE INSERTED INTO AN INSULIN VIAL ATTEMPTING TO DRAW UP INSULIN, NOTHING WOULD HAPPEN. THE INSULIN COULD NOT BE PULLED UP INTO THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768131 VANISHPOINT INSULIN SYRINGE SYRINGE ANTI-STICK MEG RETRACTABLE TECHNOLOGIES, INC. 10211 F180109
    768132 VANISHPOINT INSULIN SYRINGE SYRINGE ANTI-STICK MEG RETRACTABLE TECHNOLOGIES, INC. 10211 F180109
    768133 VANISHPOINT INSULIN SYRINGE SYRINGE ANTI-STICK MEG RETRACTABLE TECHNOLOGIES, INC. 10221 F180109
    768134 VANISHPOINT INSULIN SYRINGE SYRINGE ANTI-STICK MEG RETRACTABLE TECHNOLOGIES, INC. 10211 F180109
    768135 VANISHPOINT INSULIN SYRINGE SYRINGE ANTI-STICK MEG RETRACTABLE TECHNOLOGIES, INC. 10211 F180109

    Patients

    Seq Age Sex Outcome Treatment
    1