BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KANGAROO

    MDR report key: 24203389 · Received January 28, 2026

    Report

    Report Number
    1423537-2026-00022
    Event Type
    Malfunction
    Date Received
    January 28, 2026
    Date of Event
    January 9, 2026
    Report Date
    March 13, 2026
    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

    ADDITIONAL PRODUCT CODE: PIF, ADDITIONAL 510K NUMBER: K180622. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION THE RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 0

    A DEVICE WAS NOT RECEIVED FOR INVESTIGATION, BUT A PHOTO WAS PROVIDED. THE PHOTO WAS EVALUATED AND THE REPORTED CONDITION WAS OBSERVED. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ABNORMAL PROCESS CONDITIONS WERE PRESENT DURING THE MANUFACTURING OF THE PRODUCT THAT COULD HAVE LED TO THE OBSERVED CONDITION. THE DHR REVIEW SHOWED THAT ALL ACCEPTANCE CRITERIA INSPECTIONS PER ESTABLISHED SAMPLING LEVELS WERE WITHIN ACCEPTABLE LIMITS DURING THE PRODUCTION PROCESS. ADDITIONALLY, NO NONCONFORMANCES WERE OPENED DURING THE MANUFACTURING PROCESS. THE INVESTIGATION WAS CONDUCTED WITH THE INTERDISCIPLINARY TEAM. ALL PROCESSES WERE REVIEWED AND VERIFIED TO BE FUNCTIONING CORRECTLY. NO ABNORMAL CONDITIONS WERE FOUND THAT COULD TRIGGER THE REPORTED CONDITION. A SUPPLIER CORRECTIVE ACTION REQUEST HAS BEEN SENT TO THE SUPPLIER TO CONDUCT A MORE IN-DEPTH INVESTIGATION RELATED TO THIS TYPE OF FAILURE. ¿WE WILL CONTINUE TO MONITOR RELATED REPORTS TO DETERMINE IF ADDITIONAL ACTIONS ARE NECESSARY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THEY RECEIVED A CALL FROM THE PERSON IN CHARGE STATING THAT THE PROBE HAD BURST AND WAS LEAKING. IT WAS THEN REPLACED WITH A TEMPORARY PROBE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THEY RECEIVED A CALL FROM THE PERSON IN CHARGE STATING THAT THE PROBE HAD BURST AND WAS LEAKING. IT WAS THEN REPLACED WITH A TEMPORARY PROBE. PER ADDITIONAL INFORMATION PROVIDED, THE LEAK STARTED THROUGH THE PIPE, AND AFTER THAT, THE BALLOON BURST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260154 KANGAROO TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT CARDINAL HEALTH 200, LLC 8884720247 2401208764 10192253011562

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown