BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KANGAROO

    MDR report key: 20031002 · Received August 22, 2024

    Report

    Report Number
    1423537-2024-00120
    Event Type
    Injury
    Date Received
    August 22, 2024
    Date of Event
    August 13, 2024
    Report Date
    September 23, 2024
    Manufacturer
    CARDINAL HEALTH, INC.
    Product Code
    KNT
    UDI-DI
    10884521583030
    PMA / PMN Number
    K833621
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD (DHR) REVIEW SHOWED ALL INSPECTION RESULTS WERE CARRIED OUT AND WERE WITHIN ACCEPTABLE CRITERIA AS PER ESTABLISHED SAMPLING PLAN LEVELS AND QUALITY PROCEDURES. ONE SAMPLE WAS RECEIVED FOR EVALUATION. THE SAMPLE WAS VISUALLY INSPECTED SHOWING THE SAMPLE ARRIVED WITHOUT THE BOLUS, WHICH IS CONNECTED TO THE ADAPTER. THE REPORTED CONDITION WAS CONFIRMED. THE EXACT ROOT CASE COULD NOT BE DETERMINED. BASED ON THE HISTORICAL REVIEW, A CORRECTIVE AND PREVENTATIVE ACTION (CAPA) WAS GENERATED. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED WHEN THE DOBHOFF TUBE WAS REMOVED FROM THE PATIENT, THE METAL END TIP DISCONNECTED FROM THE TUBE AND REMAINED INSIDE THE PATIENT'S STOMACH. THE TIP OF THE TUBE WAS REMOVED VIA AND EGD (ESOPHAGOGASTRODUODENOSCOPY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25501 KANGAROO TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT CARDINAL HEALTH, INC. 8884721252E 2333106964 10884521583030

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other