BEUDAMED
    FDA Adverse Event Other Summary report: N

    VANISHPOINT SYRINGE

    MDR report key: 595339 · Received April 20, 2005

    Report

    Report Number
    595339
    Event Type
    Other
    Date Received
    April 20, 2005
    Date of Event
    March 8, 2005
    Report Date
    April 20, 2005
    Manufacturer
    RETRACTABLE TECHNOLOGIES, INC.
    Product Code
    MEG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A NURSE ATTEMPTED TO GIVE AN INJECTION OF DMPA INTO A PATIENT'S RIGHT DELTOID WITH A VANISHPOINT SYRINGE. THE SYRINGE PLUNGER WOULD NOT ADVANCE. THE SYRINGE WAS DISCARDED. THE INJECTION WAS GIVEN SUCCESSFULLY WITH ANOTHER SYRINGE INTO THE PATIENT'S LEFT DELTOID. THE RTI REPRESENTATIVE WAS NOTIFIED; THE REP CONTACTED THE CLINIC. SYRINGE SAMPLES FROM THE LOT AS WELL AS SAMPLES FROM ANOTHER LOT WERE SENT TO RTI REGULATORY AFFAIRS FOR EVALUATION. THE RTI REP MET WITH STAFF IN THE CLINIC AND RECOMMENDED A LARGER GAUGE NEEDLE FOR VISCOUS MEDICATION.

    Description of Event or Problem · 1

    THE INVOLVED PRODUCT WAS NOT AVAILABLE FOR TESTING SO AN INVESTIGATION WAS PERFORMED ON ASSOCIATED SAMPLES. THE SAMPLES WERE SUBMITTED FOR TESTING AGAINST QUALITY ASSURANCE SPECIFICATIONS. THE INVESTIGATION INDICATED NO FAILURES FOR SPECIFICATIONS AND NO COMPONENT DAMAGE. AN INVESTIGATION RESULTS LETTER WAS SENT TO THE FACILITY. WE ALSO PERFORMED A REVIEW OF THE DEVICE HISTORY RECORD AND NO ANOMALIES WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VANISHPOINT SYRINGE 3CC SYRINGE , 23 GAUGE X 1 INCH NEEDLE MEG RETRACTABLE TECHNOLOGIES, INC. * A0409014

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR