BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PMI HUBER NEEDLE 20G X 3.5 ".

    MDR report key: 5628323 · Received April 29, 2016

    Report

    Report Number
    MW5062037
    Event Type
    Malfunction
    Date Received
    April 29, 2016
    Date of Event
    March 3, 2016
    Report Date
    April 19, 2016
    Manufacturer
    LUER PROGRESSIVE MEDICAL INC.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE ACCESSING A BARIATRIC LAP BAND PORT THE NEEDLE BROKE AT THE HUB CAUSING DIFFICULTY TO RETRIEVE FROM THE PT. NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274762 PMI HUBER NEEDLE 20G X 3.5 ". PMI HUBER NEEDLE FEMALE FMI LUER PROGRESSIVE MEDICAL INC. 160203

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR