BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KANGAROO

    MDR report key: 24273809 · Received February 5, 2026

    Report

    Report Number
    1423537-2026-00025
    Event Type
    Malfunction
    Date Received
    February 5, 2026
    Date of Event
    January 28, 2026
    Report Date
    April 28, 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
    KY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD 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. THE MANUFACTURING PROCESS WAS REVIEWED AND NO ABNORMALITIES WERE IDENTIFIED. MULTIPLE CAMERA TESTS ARE PERFORMED DURING PRODUCTION AND NO RISK OF CAMERA DETACHMENT ESCAPING THE MANUFACTURING PROCESS WAS IDENTIFIED. A DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE AFFECTED PRODUCT COULD NOT BE EVALUATED TO CONFIRM THE REPORTED FAILURE MODE. BASED ON ALL AVAILABLE INFORMATION, A ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. WE WILL CONTINUE TO MONITOR RELATED REPORTS TO DETERMINE IF ADDITIONAL ACTIONS ARE NECESSARY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE DEVICE WAS PLACED IN A PATIENT AND WHEN THEY REMOVED THE TUBE, THE CAMARA HAD DETACHED AND IT'S ASSUMED IT'S INDWELLING IN THE PATIENT. PER ADDITIONAL INFORMATION PROVIDED BY THE REPORTER, NEITHER THE SERIAL NUMBER OR LOT NUMBER ARE AVAILABLE. THE TUBE WAS INITIALLY PLACED ON EITHER JANUARY 04TH OR 13TH AND WAS REMOVED ON JANUARY 28TH. IT IS UNKNOWN IF THE TIP WAS CONFIRMED TO BE IN THE PATIENT'S BODY OR IF/HOW IT WAS POTENTIALLY REMOVED. HOWEVER, IT WAS STATED THAT NO FURTHER MEDICAL INTERVENTION/TREATMENT WAS PROVIDED AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67252 KANGAROO TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT CARDINAL HEALTH 200, LLC 461055E 10192253007855

    Patients

    Seq Age Sex Outcome Treatment
    1