BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KANGAROO

    MDR report key: 20078488 · Received August 27, 2024

    Report

    Report Number
    1423537-2024-00137
    Event Type
    Injury
    Date Received
    August 27, 2024
    Report Date
    August 27, 2024
    Manufacturer
    CARDINAL HEALTH, INC.
    Product Code
    KNT
    UDI-DI
    10884521582996
    PMA / PMN Number
    K833621
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD WAS REVIEWED AND INDICATED THAT THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARDS. THE DEVICE WAS MANUFACTURED ON FEBRUARY 29, 2024. THERE WERE NO PHYSICAL SAMPLES OR PHOTOS RECEIVED FOR INVESTIGATION. BECAUSE A SAMPLE WAS NOT RETURNED, WE WERE UNABLE TO PERFORM FUNCTIONAL AND VISUAL EVALUATIONS TO CONFIRM THE REPORTED CONDITION AND DETERMINE THE ROOT CAUSE. IF A SAMPLE IS RECEIVED AT A LATER DATE, THE COMPLAINT WILL BE REOPENED, AND THE INVESTIGATION WILL BE UPDATED ACCORDINGLY. A CORRECTIVE ACTION IS NOT APPLICABLE AT THIS TIME. FUNCTIONAL TESTING AND VISUAL INSPECTIONS ARE PERFORMED ACCORDING TO OUR CURRENT QUALITY STANDARDS AND INSPECTION PROCEDURES. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A PNEUMOTHORAX RESULTING FROM THE CARDINAL KANGAROO DOBHOFF TUBE. THE CLINICIAN STATED THAT THE TIP OF THE STYLET IS VERY STIFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158105 KANGAROO TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT CARDINAL HEALTH, INC. 8884721088E 2405901764 10884521582996

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other