BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KANGAROO

    MDR report key: 6289518 · Received January 31, 2017

    Report

    Report Number
    6289518
    Event Type
    Malfunction
    Date Received
    January 31, 2017
    Date of Event
    January 3, 2017
    Report Date
    January 3, 2017
    Manufacturer
    COVIDIEN (MEDTRONIC)
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT HAD THE KANGAROO NASOGASTRIC TUBE PLACED AS PER MANUFACTURER'S GUIDELINES. PLACEMENT WAS CONFIRMED. GUIDE WIRE WAS VERY DIFFICULT TO REMOVE. PROVIDER HAD TO PULL EXTREMELY HARD TO REMOVE THE GUIDE WIRE. THIS HAS BEEN HAPPENING WITH THIS PRODUCT. THE PATIENT WAS NOT HARMED. MANUFACTURER RESPONSE FOR NASOGASTRIC TUBE, KANGAROO (PER SITE REPORTER): AWAITING FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72099 KANGAROO TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT COVIDIEN (MEDTRONIC) 532081964X

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR NO