BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KANGAROO

    MDR report key: 25057542 · Received May 1, 2026

    Report

    Report Number
    1423537-2026-00138
    Event Type
    Malfunction
    Date Received
    May 1, 2026
    Date of Event
    April 8, 2026
    Report Date
    May 6, 2026
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    KNT
    UDI-DI
    10192253007855
    PMA / PMN Number
    K163002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PRODUCT CODE: KNT. ADDITIONAL 510K NUMBER: K123555. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE PATIENT ATTEMPTED TO PULL OUT THE IRIS TUBE AND THE NURSE INTERVENED BY GRASPING THE TUBE NEAR THE NARE TO PREVENT REMOVAL OF BOTH THE TUBE AND THE BRIDLE. DURING THIS EVENT, THE TUBE SPLIT AT THE 84CM MARK BETWEEN THE POINT WHERE THE NURSE WAS HOLDING IT AND WHERE THE PATIENT WAS PULLING. NO HARM TO THE PATIENT REPORTED. PER ADDITIONAL INFORMATION PROVIDED, THE REMAINDER OF THE TUBE WAS REMOVED BY HAND, NO ADDITIONAL PROCEDURES WERE PERFORMED. A NEW TUBE WAS NOT PLACED AFTER THE REMOVAL OF THIS TUBE AS THE PATIENT WAS COMBATIVE AND THE MEDICAL TEAM OPTED NOT TO REINSERT ANOTHER TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385569 KANGAROO TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT CARDINAL HEALTH 200, LLC 461055E 1055081325 10192253007855

    Patients

    Seq Age Sex Outcome Treatment
    1