BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEO DEVICES FTS 5.0 P-EO

    MDR report key: 5221745 · Received November 13, 2015

    Report

    Report Number
    5221745
    Event Type
    Malfunction
    Date Received
    November 13, 2015
    Date of Event
    October 29, 2015
    Report Date
    November 4, 2015
    Manufacturer
    NEO DEVICES, INC
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE PLACING FEEDING TUBE IN INFANT I NOTICED THAT THE NUMBERS THAT ARE ON THE TUBE IN REGARDS TO MEASUREMENT AND PLACEMENT WERE PLACED BACKWARDS. NOTIFIED ANOTHER NURSE TO VALIDATE CONCERNS, CONFIRMED THAT THE NUMBERS WERE PRINTED BACKWARDS. INFORMED BABY'S MOTHER THAT TUBE IS DEFECTIVE AND NEEDS TO BE REMOVED. HAVE WE CHECKED THE OTHER NGT'S IN THIS AREA OR FROM THE SAME LOT NUMBER, ETC. TO SEE IF THERE ARE OTHERS THAT ARE DEFECTIVE: NONE OTHER FOUND IN STOCK. ALL NGT'S WERE CHECKED IN THE NICU AND SUPPLY AREA - ALL GOOD TO GO. MATERIAL MANAGEMENT, TAKE A LOOK IN YOUR AREA. THE STOREROOM STOCK HAS BEEN CHECKED, DIFFERENT LOT NUMBERS GOOD TO GO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751773 NEO DEVICES FTS 5.0 P-EO NEO DEVICES - FEEDING TUBE (POLYURETHANE ENTERAL FEEDING TUBE WITH RADIOPAQUE S KNT NEO DEVICES, INC FTS5.0P-EO 5F038M-R

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR