BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIFLO/ROSS ENTERAL FEEDING TUBES (NG)

    MDR report key: 1171443 · Received September 17, 2008

    Report

    Report Number
    1527460-2008-00859
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Date of Event
    August 1, 2008
    Report Date
    August 20, 2008
    Manufacturer
    ABBOTT NUTRITION
    Product Code
    KNT
    PMA / PMN Number
    K992494
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED, THE PRODUCT WAS DISCARDED. ABBOTT NUTRITION STANDARD PROCEDURE INCLUDES ATTEMPTING TO OBTAIN ALL REQUIRED INFO FROM THE SOURCE.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT A NASOENTERIC TUBE WAS FOUND TO BE OBSTRUCTED AND WHEN IT WAS REMOVED FROM THE PT, THE TUNGSTEN BOLUS WAS MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIFLO/ROSS ENTERAL FEEDING TUBES (NG) KNT, TUBES, GASTROINTESTINAL AND ACCESSORIES KNT ABBOTT NUTRITION 00475

    Patients

    Seq Age Sex Outcome Treatment
    1