BEUDAMED
    FDA Adverse Event Summary report: N

    VANISHPOINT

    MDR report key: 3195852 · Received June 24, 2013

    Report

    Report Number
    MW5030696
    Date Received
    June 24, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 24, 2013
    Manufacturer
    RETRACTABLE TECHNOLOGIES
    Product Code
    MEG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    ONE OF MY MAS WENT TO OPEN A NEEDLE TODAY AND IT WAS FURRY (COVERED IN SOME SORT OF LINT). PACKAGE WAS INTACT. VANISHPOINT 3CC 25G X 5/8: REF#10301, LOT#A130201, EXP 01/18. IT'S PRETTY IMPRESSIVE. ON MY DESK BECAUSE (B)(6) WILL WANT TO SEE IT AND PICS DON'T DO IT JUSTICE. (B)(6), RN, (B)(6) MEDICAL FOUNDATION, (B)(6). ON FRIDAY (B)(6) WE CONTACTED VANISHPOINT AND SPOKE WITH THEIR REGULATORY PERSON NAMED (B)(6). WE ALSO SENT NOTIFICATION THROUGHOUT THE (B)(6) MEDICAL FOUNDATION CLINICS FOR EVERYONE TO INSPECT STOCK ON HAND. WE THEN RECEIVED ANOTHER REPORT OF A "FURRY NEEDLE" THAT HAD BEEN DISCARDED EARLIER IN THE WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286466 VANISHPOINT 3CC 25G X 5/8 MEG RETRACTABLE TECHNOLOGIES 10301 A130201

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention