BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KANGAROO

    MDR report key: 22292921 · Received June 19, 2025

    Report

    Report Number
    1423537-2025-00260
    Event Type
    Malfunction
    Date Received
    June 19, 2025
    Date of Event
    April 3, 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

    ONE DEVICE WAS RECEIVED FOR INVESTIGATION. THE DEVICE WAS INSPECTED, AND THE REPORTED CONDITION WAS OBSERVED. 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. THE AFFECTED COMPONENT IS PRODUCED BY AN EXTERNAL SUPPLIER; OUR ASSEMBLY PROCESS CONSISTS ONLY OF A PICK AND PLACE OPERATION FOR THIS MATERIAL. 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.

    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.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE BROKEN BLADDER CAUSED INTERNALLY LEAKAGE. PER CUSTOMER, EVERYTHING WORKS NORMALLY UNTIL THE "BLADDER" BREAKS, FORCING THEM TO GET THE NURSE BACK TO CHANGE THE TUBE. THE PATIENT HAS A NURSE WHO PLACES THEM AND CHANGES THEM, AND SHE IS SPECIALIZED IN TUBE FEED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT "BLADDER BREAKS" REFERS TO BALLOON SPLITS/BREAKS. THERE WAS NO HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1767194 KANGAROO TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT CARDINAL HEALTH, INC. 8884720205 2226411964 10884521007291

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown