BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMNO

    MDR report key: 6063168 · Received October 28, 2016

    Report

    Report Number
    6063168
    Event Type
    Malfunction
    Date Received
    October 28, 2016
    Date of Event
    September 23, 2016
    Report Date
    October 4, 2016
    Manufacturer
    CAREFUSION 2200, INC.
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WE HAVE HAD THIS DEVICE FAIL THREE TIMES TO WHERE WE ARE UNABLE TO INSERT THE BIOPSY DEVICE INTO THE INTRODUCER. ONE OF THE DEVICES WE HAD IN THE PATIENT AND WERE ABLE TO OBTAIN ONE SAMPLE (ALTHOUGH IT WAS A STRUGGLE TO GET THE DEVICE INTO THE INTRODUCER). HOWEVER, WHEN WE TRIED TO RE-INSERT THE DEVICE, IT WOULDN'T GO PAST WHERE THE PLASTIC HUB IS CRIMPED ONTO THE NEEDLE. WE OPENED TWO OTHER DEVICES AND ATTEMPTED TO INSERT THE DEVICE INTO THE INTRODUCER BEFORE PUTTING IT INTO THE PATIENT AND WERE UNSUCCESSFUL. WE OPENED A NEW BOX WITH A DIFFERENT LOT NUMBER AND WERE ABLE TO FINISH THE PROCEDURE. REP STATEMENT: "I WONDER IF IT'S THE OLD PRODUCT BEFORE WE MADE UPGRADES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715423 TEMNO INSTRUMENT, BIOPSY KNW CAREFUSION 2200, INC. 20G X 15CM 0000938998

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR IT WAS A CT GUIDED LIVER BIOPSY. A 19-GAUGE GUIDE