BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KANGAROO

    MDR report key: 22652221 · Received July 29, 2025

    Report

    Report Number
    1423537-2025-00296
    Event Type
    Malfunction
    Date Received
    July 29, 2025
    Report Date
    August 27, 2025
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    KNT
    UDI-DI
    10192253011562
    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. THERE WERE NO SAMPLES 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 AT THIS TIME. HOWEVER, 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

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED. ADDITIONAL PRODUCT CODE (D2A): PIF. ADDITIONAL 510(K)NUMBER (G4): K932295.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE G-TUBE BALLOON RUPTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1062863 KANGAROO TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT CARDINAL HEALTH 200, LLC 8884720247 2400216664 10192253011562

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male