BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VANISH POINT INSULIN SYRINGES 1CC - 29G X 1/2"

    MDR report key: 3365769 · Received September 19, 2013

    Report

    Report Number
    MW5031976
    Event Type
    Malfunction
    Date Received
    September 19, 2013
    Date of Event
    September 15, 2013
    Report Date
    September 18, 2013
    Manufacturer
    RETRACTABLE TECHNOLO...
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    VANISH POINT INSULIN SYRINGES 1CC - 29G X 1/2" LOT# F121006 - RETRACTABLE NEEDLE DID NOT RETRACT AFTER USE AND THE NURSE SUSTAINED A FINGERSTICK INJURY. THE PT WAS NOT AFFECTED. THESE SYRINGES ARE USED THROUGHOUT OUR FACILITY (NURSING HOME). NURSES HAVE REPORTED THEY "NEED TO PUSH EXTRA HARD" TO GET THE NEEDLES TO RETRACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473945 VANISH POINT INSULIN SYRINGES 1CC - 29G X 1/2" VANISH POINT SYRINGE FMF RETRACTABLE TECHNOLO... F121006

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other