BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIBLE ENTERAL FEEDING TUBE

    MDR report key: 129604 · Received October 22, 1997

    Report

    Report Number
    MW1012393
    Event Type
    Malfunction
    Date Received
    October 22, 1997
    Date of Event
    October 10, 1997
    Report Date
    October 20, 1997
    Manufacturer
    ABBOTT LABORATORIES/ROSS PRODUCTS DIV.
    Product Code
    BSS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN THE NURSE REMOVED THE FEEDING TUBE. IT WAS FOUND TO BE KNOTTED AT THE TIP WITH DARK BROWNISH FLUID 1/3 UP ON THE OUTSIDE OF THE TUBE. THE PT SUSTAINED NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIBLE ENTERAL FEEDING TUBE ENTERAL FEEDING TUBE BSS ABBOTT LABORATORIES/ROSS PRODUCTS DIV. 473 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR
    2