BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANDERSEN

    MDR report key: 513460 · Received January 9, 2004

    Report

    Report Number
    1053825-2003-00002
    Event Type
    Other
    Date Received
    January 9, 2004
    Date of Event
    November 22, 2003
    Report Date
    January 8, 2004
    Manufacturer
    ANDERSEN PRODUCTS, INC.
    Product Code
    FPD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SUCCESSFUL INSERTION OF ANDERSEN TUBE. FIRST STYLET COULD NOT BE WITHDRAWN FROM NG TUBE DUE TO HANDLE BREAKING OFF STYLET. SECOND STYLET HANDLE ALSO BROKE OFF DURING WITHDRAWAL. ANOTHER TUBE INSERTED WITH SUCCESS. NO PARTS WERE LEFT IN PT AND THERE WAS NO PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANDERSEN NG TUBE FPD ANDERSEN PRODUCTS, INC. AN 10.11 230058

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other