BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VANISHPOINT

    MDR report key: 572694 · Received February 9, 2005

    Report

    Report Number
    572694
    Event Type
    Malfunction
    Date Received
    February 9, 2005
    Date of Event
    January 24, 2005
    Report Date
    February 9, 2005
    Manufacturer
    RETRACTABLE TECHNOLOGIES, INC.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FIRST FOUND A SYRINGE WAS CRACKED, 3CC GAUGE 1/2 INCH NEEDLE. UPON FURTHER CHECKING OF THE BOX, THE FOLLOWING WAS NOTED: 1. ONE SYRINGE WITH THE NEEDLE BENT AND PROTRUDING THROUGH THE CAP AND THE PACKAGING WAS OTHERWISE UNOPENED. 2. TWO SYRINGES WHERE THE NEEDLE SEEMS TO OFFER MORE RESISTANCE TO WITHDRAWING OR INJECTING FLUID AS IF THE LUMEN IS NOT AS FULLY PATENT AS THE OTHER SYRINGES. 3. TWO SYRINGES WITH .5 INCH LINE ON THE BARREL, LOOKED LIKE A SCRATCH ETCHED IN THE BARREL THAT YOU CAN FEEL BUT NOT GOING THROUGH OR CAUSING A LEAK. A MESSAGE WAS LEFT FOR THE RTI, RETRACTABLE TECHNOLOGIES, INC. REPRESENTATIVE AND THE SYRINGE SAMPLES FROM THIS DEFECTIVE LOT WILL BE SENT TO RTI REGULATORY AFFAIRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VANISHPOINT SYRINGE FMF RETRACTABLE TECHNOLOGIES, INC. * 487A

    Patients

    Seq Age Sex Outcome Treatment
    1 *