BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KANGAROO

    MDR report key: 23780916 · Received December 11, 2025

    Report

    Report Number
    1423537-2025-00503
    Event Type
    Malfunction
    Date Received
    December 11, 2025
    Date of Event
    October 28, 2025
    Report Date
    January 13, 2026
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    KNT
    UDI-DI
    10192253011524
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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. A DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE AFFECTED PRODUCT COULD NOT BE EVALUATED TO CONFIRM THE REPORTED FAILURE MODE. AS SUCH, A 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 510K 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 DURING THE PROCEDURE, THE GASTROSTOMY TUBE WAS DEFECTIVE ACCORDING TO THE MEDICAL TEAM. THE DOCTOR REPORTED THE TUBE HAD A HOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2721405 KANGAROO TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT CARDINAL HEALTH 200, LLC 8884720205 2419100164 10192253011524

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown