BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VANISHPOINT SYRINGE

    MDR report key: 8883422 · Received August 9, 2019

    Report

    Report Number
    MW5088937
    Event Type
    Malfunction
    Date Received
    August 9, 2019
    Report Date
    August 7, 2019
    Manufacturer
    RETRACTABLE TECHNOLOGIES, INC.
    Product Code
    MEG
    UDI-DI
    00613703103901
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WE HAVE NOTICED CHANGES IN THE QUALITY OF VANISHPOINT 3 ML 25G X 1" SYRINGES OVER THE PAST YEAR. IN THREE OF OUR OFFICES, NURSES WITH 20-35+ YEARS OF EXPERIENCE HAVE NOTED THE PRE-ATTACHED NEEDLE BENDS, BREAKS OFF AT THE HUB, OR SEEMS DULL AND TAKES EXTRA PRESSURE TO PUNCTURE THE SKIN. ONE NEEDLE HAD NO LEVEL. WE NOTIFIED RETRACTABLE TECHNOLOGIES, INC., AND SENT SYRINGES FROM LOT NUMBER A161204 (EXP 11/28/2021) FOR TESTING. WE RECEIVED A LETTER FROM RETRACTABLE TECHNOLOGIES, AND E-MAIL FROM ONE OF THEIR REPS, ADVISING THAT THE SYRINGES WERE FINE BUT THAT OUR NURSES MAY NEED MORE TRAINING. WE FEEL THAT HAS BEEN A CHANGE IN THE QUALITY OF THE PRODUCT, AND THAT OUR VERY EXPERIENCED IMMUNIZATION NURSES DO NOT NEED FURTHER TRAINING ON USING THE SYRINGES. OUR MEDICAL DIRECTOR ASKED THAT WE SUBMIT THIS IN CASE OTHER AGENCIES HAVE NOTICED QUALITY ISSUES WITH VANISHPOINT SYRINGES. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671520 VANISHPOINT SYRINGE SYRINGE, ANTISTICK MEG RETRACTABLE TECHNOLOGIES, INC. 3ML 25GX1" A161204 00613703103901

    Patients

    Seq Age Sex Outcome Treatment
    1