BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPAT 10FR NASOENTRIC FEEDING TUBE

    MDR report key: 2793700 · Received October 12, 2012

    Report

    Report Number
    2110851-2012-00001
    Event Type
    Malfunction
    Date Received
    October 12, 2012
    Date of Event
    September 1, 2012
    Report Date
    October 11, 2012
    Manufacturer
    NESTLE HEALTHCARE NUTRITION, INC
    Product Code
    KNT
    PMA / PMN Number
    K834554
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    FACILITY REPORTED "HOWEVER TODAY THE WEIGHT APPEARS TO HAVE BROKEN UP INTO PIECES". THE PRODUCT IS MANUFACTURED WITH 4 INDIVIDUAL TUNGSTEN WEIGHTS IN THE TIP-FORMED BOLUS TUBE.

    Description of Event or Problem · 1

    A COMPAT ENTERAL FEEDING TUBE WAS PLACED IN A PT ON (B)(6). ADVANCEMENT OF THE TUBE TO THE INTESTINE REQUIRES SERIAL ABDOMINAL X-RAYS TO ASSURE ADEQUATE PLACEMENT. ON THE 3RD X-RAY IT WAS FOUND THE METAL WEIGHT ON THE DISTAL END OF THE FEEDING TUBE HAD BECOME DISCONNECTED FROM THE REST OF THE TUBE. DAILY X-RAYS HAVE BEEN DONE SINCE THEN TO ASSESS THE PROGRESS OF THE METAL WEIGHT AND WAS ASSESSED TO BE INTACT AND SLOWLY PROGRESSING THROUGH THE SMALL INTESTINE. HOWEVER, TODAY THE WEIGHT APPEARS TO HAVE BROKEN UP INTO PIECES. THE PRODUCT IS MANUFACTURED WITH FOUR INDIVIDUAL TUNGSTEN WEIGHTS IN THE TIP FORMED BOLUS TUBE. THIS IS THE REASON FOR THE PRODUCT APPEARING TO BE BROKEN INTO PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPAT 10FR NASOENTRIC FEEDING TUBE TUBE, FEEDING KNT NESTLE HEALTHCARE NUTRITION, INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other