BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KANGAROO

    MDR report key: 23780846 · Received December 11, 2025

    Report

    Report Number
    1423537-2025-00502
    Event Type
    Malfunction
    Date Received
    December 11, 2025
    Date of Event
    October 28, 2025
    Report Date
    January 7, 2026
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    KNT
    UDI-DI
    10192253011524
    PMA / PMN Number
    K180622
    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 SAMPLE WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE AFFECTED DEVICE COULD NOT BE EVALUATED TO CONFIRM THE REPORTED FAILURE MODE.¿ AS SUCH, A ROOT CAUSE COULD NOT BE DETERMINED. A SUPPLIER CORRECTIVE ACTION REQUEST HAS BEEN SENT TO THE SUPPLIER. 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 DEFECT IN THE CUFF. PER ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER, THE BALLOON DEFLATED ON ITS OWN IN LESS THAN 30 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2772622 KANGAROO TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT CARDINAL HEALTH 200, LLC 8884720205 2419100164 10192253011524

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown