BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER

    MDR report key: 2021719 · Received March 14, 2011

    Report

    Report Number
    MW5019798
    Event Type
    Malfunction
    Date Received
    March 14, 2011
    Date of Event
    February 23, 2011
    Report Date
    March 8, 2011
    Manufacturer
    BD VACUTAINER SYSTEMS, PREANALYTICAL SOLUTIONS
    Product Code
    JKA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ONCE ECLIPSE WAS ATTACHED TO VACUTAINER SLEEVE WHEN YOU TRIED TO ALIGN BEVEL BY MOVING SAFETY COVER - THE SAFETY COVER SNAPPED OFF LEAVING NO SAFETY DEVICE OR THE NEEDLE BECAUSE UNSECURED FROM SLEEVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD VACUTAINER ECLIPSE JKA BD VACUTAINER SYSTEMS, PREANALYTICAL SOLUTIONS 0334330

    Patients

    Seq Age Sex Outcome Treatment
    1