BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANISH POINT INSULIN SYRINGE, 29G X .5" LML

    MDR report key: 3874073 · Received June 10, 2014

    Report

    Report Number
    MW5036572
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 10, 2014
    Manufacturer
    RETRACTABLE TECHNOLOGIES, INC
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    OUR INSTITUTION IS CURRENTLY USING THE VANISH POINT LCC 29G X .5" INSULIN SYRINGES, REF (B)(4). IT WAS REPORTED TO ME THAT THREE OF OUR STAFF MEMBERS HAVE HAD PROBLEMS WITH THE RETRACTION MECHANISM WITHIN THE PAST MONTH; THE NEEDLES RETRACTED WHEN ACTIVATED BUT THEN THE NEEDLE SLID BACK OUT. ON THE DATE NOTED ABOVE, A STAFF MEMBER UTILIZED A SYRINGE THAT DID NOT RETRACT. THE LOT NUMBER INVOLVED ON (B)(6) 2014 WAS F131001. WE HAVE NOT HAD ANY ACCIDENTAL NEEDLE STICKS WITH THIS PRODUCT AS THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338496 VANISH POINT INSULIN SYRINGE, 29G X .5" LML INSULIN SYRINGE FMI RETRACTABLE TECHNOLOGIES, INC 10211 F131001

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention