BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VANISHPOINT

    MDR report key: 5303255 · Received December 11, 2015

    Report

    Report Number
    MW5058529
    Event Type
    Malfunction
    Date Received
    December 11, 2015
    Date of Event
    December 10, 2015
    Report Date
    December 11, 2015
    Manufacturer
    RETRACTABLE TECHNOLOGIES, INC.
    Product Code
    MEG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    2

    Narratives

    Description of Event or Problem · 1

    WHILE GIVING A (B)(6) INFANT A PENTACEL IMMUNIZATION WITH A VANISHPOINT SYRINGE, THE NEEDLE CAME APART FROM THE SYRINGE AND STUCK IN THE BABY'S THIGH. THE ENTIRE NEEDLE WAS INTACT AND WAS EASILY REMOVED FROM THE BABY'S LEG. NO INJURY TO CHILD. IT WAS PRODUCT MALFUNCTION. THE NEEDLE SEPARATED FROM THE SYRINGE WHEN IT WAS SUPPOSED TO RETRACT UP INTO THE SYRINGE. IT WAS A VANISHPOINT SYRINGE FROM RETRACTABLE TECHNOLOGIES, INC. IT WAS A 25 GA. 1 INCH, 1 CC SYRINGE. LOT #G141204. EXP. DATE (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820081 VANISHPOINT SYRINGE MEG RETRACTABLE TECHNOLOGIES, INC. G141204

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO