BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.0 FR X 40 CM RADIOPAQUE POLYURETHANE ENTERAL FEEDING TUBE

    MDR report key: 749079 · Received July 28, 2006

    Report

    Report Number
    749079
    Event Type
    Malfunction
    Date Received
    July 28, 2006
    Date of Event
    July 18, 2006
    Report Date
    July 28, 2006
    Manufacturer
    NEO DEVICES , INC.
    Product Code
    FPD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US

    Narratives

    Description of Event or Problem · 1

    THIS HOSPITAL RECENTLY BEGAN USING NEO DEVICES INC. 4.0 ENTERAL POLYURETHANE FEEDING TUBES. STAFF NOTICED THAT THESE TUBES ARE CRACKING AT THE HUB CAUSING LEAKS AND THE NEED FOR EARLY REPLACEMENT OF THE TUBE. WE WERE INFORMED FROM MASTER MEDICAL, DISTRIBUTOR OF NEO DEVICES THAT AN AIR BUBBLE IN THE MOLD OF THE POLYURETHANE TUBE WAS CAUSING THE HUBS TO BE WEAK AND CRACK. NEO DEVICES HAS TEMPORARILY SUPPLIED US WITH AN UNIVERSAL FEEDING TUBE WHILE THEY PREPARE SHIPMENT TO REPLACE THE ORIGINAL INVENTORY. NEO DEVICES HAS INDICATED THAT THEY HAVE CREATED A REINFORCED HUB FOR THEIR ENTERAL FEEDING TUBES TO PREVENT CRACKING IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.0 FR X 40 CM RADIOPAQUE POLYURETHANE ENTERAL FEEDING TUBE TUBING, FEEDING FPD NEO DEVICES , INC. * 6 F 028M

    Patients

    Seq Age Sex Outcome Treatment
    1 *