BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KANGAROO

    MDR report key: 23646153 · Received November 25, 2025

    Report

    Report Number
    1423537-2025-00481
    Event Type
    Malfunction
    Date Received
    November 25, 2025
    Date of Event
    November 18, 2025
    Report Date
    December 30, 2025
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    KNT
    UDI-DI
    10192253007831
    PMA / PMN Number
    K163002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE INCOMPLETE USED DEVICE WAS RECEIVED AT THE CARDINAL HEALTH DECONTAMINATION LAB FOR INVESTIGATION. THE DEVICE COULD NOT BE FORWARDED TO THE MANUFACTURING SITE FOR PHYSICAL INSPECTION DUE TO CURRENT CUSTOMS POLICIES. HOWEVER, IMAGES OF THE DEVICE WERE PROVIDED TO THE MANUFACTURING SITE FOR VISUAL EVALUATION. IN ADDITION, AN X-RAY IMAGE WAS PROVIDED BY THE CUSTOMER FOR REVIEW. THE IMAGES WERE EVALUATED, AND THE REPORTED CONDITION WAS OBSERVED. THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED AS NO LOT INFORMATION WAS PROVIDED WITHIN THE COMPLAINT. PRIOR TO A LOT¿S RELEASE, THE LOT MUST BE DEEMED ACCEPTABLE BY PASSING INSPECTIONS THAT ARE BASED ON A VALID SAMPLING PLAN. DURING PRODUCTION, INSPECTORS ROUTINELY EXAMINE A STATISTICAL SAMPLE BOTH PHYSICALLY AND VISUALLY. BASED ON ALL AVAILABLE INFORMATION, NO CONDITIONS WERE FOUND IN THE MANUFACTURING PROCESS THAT COULD TRIGGER THE OBSERVED CONDITION. AS SUCH, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. WE WILL CONTINUE TO MONITOR RELATED REPORTS TO DETERMINE IF ADDITIONAL ACTIONS ARE NECESSARY.

    Additional Manufacturer Narrative · 0

    ADDITIONAL PRODUCT CODE: PIF 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 CONCERN REGARDING AN OCCURRENCE WHERE A PATIENT IN THE SURGICAL TRAUMA UNIT WAS USING A KANGAROO IRIS FEEDING TUBE. THE FEEDING TUBE WAS CONFIRMED TO BE IN THE STOMACH, HOWEVER, WHEN THE NURSING TEAM WENT TO REMOVE THE FEEDING TUBE, IT GOT STUCK AT THE 15-20CM MARK. TO THE REPORTER'S KNOWLEDGE, THE PATIENT HAD NO CONTRAINDICATIONS FOR HAVING A FEEDING TUBE OR ANY ABNORMALITIES WITH THE PATIENT'S ANATOMY. THE PATIENT WAS COMPLAINING FROM EXPERIENCING PAIN FROM THE ATTEMPTS AT REMOVAL, WHICH LEAD TO A DOCTOR HAVING TO CUT THE TUBE AND MANIPULATE/REMOVE THE TUBE HIS/HERSELF. PER ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER, WHEN THEY CONFIRMED THE FEEDING TUBE WAS IN THE STOMACH AND WENT TO REMOVE THE STYLET, THEY COULDN'T GET IT TO BUDGE WHICH IS WHAT RESULTED IN THEM TRYING TO REPLACE THIS SPECIFIC FEEDING TUBE WITH A NEW ONE WHICH ULTIMATELY LED THEM TO HAVING ISSUES REMOVING IT FROM THE PATIENT. THIS FEEDING TUBE WAS CAUSING VERY EXCRUCIATING PAIN FOR THE PATIENT AT ROUGHLY THE 15-20CM MARK WHICH LED THE SURGEON TO CUT THE FEEDING TUBE AND EXTRACT IT IN A UNIQUE WAY THROUGH THE PATIENT'S MOUTH. IT WAS AT THIS TIME THEY NOTICED TA KNOT IN THE FEEDING TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2138117 KANGAROO TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT CARDINAL HEALTH 200, LLC 461043E 10192253007831

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown