BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVANOS

    MDR report key: 16859846 · Received May 3, 2023

    Report

    Report Number
    16859846
    Event Type
    Malfunction
    Date Received
    May 3, 2023
    Date of Event
    April 19, 2023
    Report Date
    April 28, 2023
    Manufacturer
    AVANOS MEDICAL, INC.
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT HAD BEEN HAVING WHITE MUCOUS BALLS IN STOOL AND RETCHING OVERNIGHT. TEAM DECIDED TO REMOVE NDT (NASODUODENAL (ND) FEEDING TUBE) TO REPLACE. NDT HAD BEEN IN PLACE APPROXIMATELY 2 MONTHS. UPON REMOVING TUBE, END OF TUBE WAS NOT INTACT, LOOKED LIKE THE TUBE DISINTEGRATED AND ABOUT 1CM OF TUBE WAS MISSING. KUB (KIDNEY, URETER, AND BLADDER X-RAY) WAS OBTAINED AND PART OF THE WEIGHTED TIP WAS VISIBLE. (CORFLO NASOGASTRIC FEEDING TUBE 8FR 109CM) NO PATIENT HARM, BOWEL MOVEMENT INCLUDED PASSING OF RETAINED NG TUBE PIECE. UNFORTUNATELY, PACKAGING OF THE NDT INVOLVED WOULD'VE BEEN DISCARDED SINCE NDT WAS PLACED OVER 2 MONTHS AGO. LOT NUMBER LISTED IN DEVICE SECTION IS FROM CURRENT STOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2195354 AVANOS TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT AVANOS MEDICAL, INC. 40-7438 30156489

    Patients

    Seq Age Sex Outcome Treatment
    1 365 DA Female