BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VANISTPOINT SYRINGE

    MDR report key: 3111619 · Received May 7, 2013

    Report

    Report Number
    MW5030121
    Event Type
    Malfunction
    Date Received
    May 7, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 7, 2013
    Manufacturer
    RETRACTABLE TECHNOLOGIES INC.
    Product Code
    MEG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    I WAS GIVING THE PT (B)(6) MONTHS INJECTIONS AND THE LAST INJECTION I GAVE WAS DTAP. WHEN THE NEEDLE RETRACTED, THE TOP CAME OFF AND NEEDLE WAS ABLE TO COME OUT OF THE BACK SIDE OF THE NEEDLE. AMOUNT: 0.5 ML, ONCE, IM. REASON FOR USE: (B)(6) MONTH WELL CHILD VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197781 VANISTPOINT SYRINGE VANISTPOINT SYRINGE, 3 ML 25G X 1", 0.50MM X 25 MM MEG RETRACTABLE TECHNOLOGIES INC. RETRACTABLE A121103, 10391

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO