BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWO-FER NEEDLE

    MDR report key: 1998848 · Received February 16, 2011

    Report

    Report Number
    MW5019466
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 20, 2011
    Manufacturer
    BAXA CORPORATION
    Product Code
    FMI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    THE NEEDLE WAS DISCONNECTED FROM THE TOP OF THE HUB WHILE USING IT TO PREPARE IV SOLUTION. THIS HAS OCCURRED AT LEAST SEVERAL TIMES IN THE PAST YEAR, ALTHOUGH IT HAD NEVER OCCURRED PREVIOUSLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TWO-FER NEEDLE STERILE 16G WITH HUBER POINT FMI BAXA CORPORATION 16G 755207

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention