BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KANGAROO

    MDR report key: 22198895 · Received June 12, 2025

    Report

    Report Number
    1423537-2025-00253
    Event Type
    Malfunction
    Date Received
    June 12, 2025
    Date of Event
    June 9, 2025
    Report Date
    August 25, 2025
    Manufacturer
    CARDINAL HEALTH, INC.
    Product Code
    KNT
    UDI-DI
    10884521007291
    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

    ADDITIONAL 510 K NUMBER: K932295. ADDITIONAL PRODUCT CODE: PIF. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD WAS REVIEWED AND INDICATED THAT THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARDS. 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. ONE DEVICE WAS RECEIVED FOR INVESTIGATION. THE DEVICE WAS INSPECTED, AND THE REPORTED CONDITION WAS OBSERVED. THE AFFECTED COMPONENT IS PRODUCED BY AN EXTERNAL SUPPLIER. A SUPPLIER CORRECTIVE ACTION REQUEST HAS BEEN SENT TO THE SUPPLIER TO FURTHER INVESTIGATE AND ADDRESS THE REPORTED CONDITION. WE WILL CONTINUE TO MONITOR RELATED REPORTS TO DETERMINE IF ADDITIONAL ACTIONS ARE NECESSARY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE BALLOON LASTED 19 DAYS AND LOST ITS VOLUME AND FILLED WITH SOME MEDICATION THAT HAD JUST BEEN ADMINISTERED. THE MEDICATION WAS YELLOW, AND THE CONTENTS OF THE BALLOON WAS ALSO YELLOW. PER CUSTOMER, NO FOOD HAD BEEN ADMINISTERED PRIOR TO THIS. THE DEVICE WAS INSERTED ON (B)(6) 2025 BY A NURSE WHO SPECIALIZES IN TUBE FEED AND FAILED ON (B)(6) 2025. THERE WAS NO HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1973102 KANGAROO TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT CARDINAL HEALTH, INC. 8884720205 2312930564 10884521007291

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown