BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KANGAROO

    MDR report key: 22196320 · Received June 12, 2025

    Report

    Report Number
    1423537-2025-00244
    Event Type
    Malfunction
    Date Received
    June 12, 2025
    Date of Event
    May 20, 2025
    Report Date
    July 12, 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

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

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED SINCE NO LOT NUMBER WAS PROVIDED. A SAMPLE WAS NOT RECEIVED FOR THE INVESTIGATION. BECAUSE A SAMPLE WAS NOT RETURNED, WE WERE UNABLE TO PERFORM A FOLLOW-UP INVESTIGATION TO INCLUDE FUNCTIONAL AND VISUAL EVALUATIONS TO CONFIRM THE ISSUE AND ROOT CAUSE ANALYSIS. HOWEVER, AS A PART OF CONTINUOUS IMPROVEMENTS, A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) HAS BEEN ISSUED TO THE SUPPLIER TO ADDRESS THE REPORTED CONDITION THROUGH A MORE ROBUST INVESTIGATION AND RESULTS OF THE INVESTIGATION WILL BE DOCUMENTED THROUGH THE REFERRED CAPA.

    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. PER CUSTOMER, THE ONE THE PATIENT IS CURRENTLY USING IS FINE SO FAR BUT HAS ONLY BEEN IN PLACE FOR 16 DAYS. THERE WAS NO HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1361137 KANGAROO TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT CARDINAL HEALTH, INC. 8884720205 10884521007291

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown