BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KANGAROO

    MDR report key: 24610970 · Received March 16, 2026

    Report

    Report Number
    1423537-2026-00071
    Event Type
    Malfunction
    Date Received
    March 16, 2026
    Date of Event
    December 2, 2025
    Report Date
    April 21, 2026
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    KNT
    UDI-DI
    10192253011548
    PMA / PMN Number
    K180622
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RECEIVED FOR INVESTIGATION AS PER THE CUSTOMER IT WAS DISCARDED BUT A PHOTO WAS PROVIDED. THE PHOTO WAS EVALUATED AND THE REPORTED CONDITION WAS OBSERVED. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED AS NO LOT INFORMATION WAS PROVIDED WITHIN THE COMPLAINT. HOWEVER, IT IS IMPORTANT TO NOTE, 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. TO FURTHER INVESTIGATE THE REPORTED CONDITION, A GEMBA ON-SITE INSPECTION OF THE MANUFACTURING PROCESS WAS CONDUCTED. ALL PROCESSES WERE REVIEWED AND THEIR CORRECT OPERATION WAS VERIFIED. NO ABNORMAL CONDITIONS WERE FOUND THAT COULD CONTINUE TO TRIGGER THE REPORTED CONDITION. A SUPPLIER CORRECTIVE ACTION REQUEST WAS GENERATED AND SENT TO THE SUPPLIER FOR FURTHER ANALYSIS OF THE REPORTED CONDITION. ADDITIONALLY, APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED OF THIS COMPLAINT FOR AWARENESS. 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: K932295. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THEY HAVE RECENTLY OBSERVED AN INCREASED INCIDENCE OF BALLOON RUPTURE RESULTING IN TUBE DISLODGEMENT. PER ADDITIONAL INFORMATION PROVIDED ON 13MAR2026, AN INCIDENCE OF A BALLOON RUPTURE OCCURRED ON (B)(6) 2025 AT 1300HR. THE G-TUBE WAS FOUND DISLODGED WITH THE BALLOON RUPTURED, AND WAS REPLACED WITH ANOTHER G-TUBE, ITEM CODE: 8884720221E, NOT 8884720221.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266072 KANGAROO TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT CARDINAL HEALTH 200, LLC 8884720221 10192253011548

    Patients

    Seq Age Sex Outcome Treatment
    1