BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUTAINER

    MDR report key: 6099610 · Received November 14, 2016

    Report

    Report Number
    6099610
    Event Type
    Malfunction
    Date Received
    November 14, 2016
    Date of Event
    August 1, 2016
    Report Date
    August 30, 2016
    Manufacturer
    BD
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FOLLOWING BLOOD DRAW BUTTERFLY PORTION OF NEEDLE CAME APART FROM NEEDLE END WHICH RESULTED IN INABILITY TO RETRACT THE NEEDLE LEAVING AN EXPOSED SHARP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750916 VACUTAINER NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BD

    Patients

    Seq Age Sex Outcome Treatment
    1