BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDINAL HEALTH

    MDR report key: 22198908 · Received June 12, 2025

    Report

    Report Number
    1423537-2025-00248
    Event Type
    Injury
    Date Received
    June 12, 2025
    Date of Event
    September 25, 2024
    Report Date
    July 15, 2025
    Manufacturer
    CARDINAL HEALTH, INC.
    Product Code
    KNT
    UDI-DI
    10884521583030
    PMA / PMN Number
    K833621
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED SINCE NO LOT NUMBER WAS PROVIDED. THERE WERE NO SAMPLES RETURNED FOR EVALUATION; THEREFORE, THE AFFECTED DEVICE COULD NOT BE EVALUATED TO CONFIRM THE REPORTED ISSUE. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. BASED ON THIS INFORMATION, NO CORRECTIVE ACTIONS ARE WARRANTED AT THIS TIME. WE WILL CONTINUE TO MONITOR RELATED REPORTS TO DETERMINE IF ADDITIONAL ACTIONS ARE NECESSARY. SECTION H10 ADDITIONAL MANUFACTURER NARRATIVE HAS BEEN UPDATED.

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED SINCE NO LOT NUMBER WAS PROVIDED. THERE WERE NO SAMPLES RETURNED FOR EVALUATION; THEREFORE, THE AFFECTED DEVICE COULD NOT BE EVALUATED TO CONFIRM THE REPORTED ISSUE.¿ AS SUCH, A ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. HOWEVER, A CORRECTIVE AND PREVENTATIVE ACTION HAS BEEN OPENED TO ADDRESS THE REPORTED ISSUE. 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.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT A DOBHOFF TUBE WAS INSERTED. THE PATIENT COMPLAINED OF DIFFICULTY BREATHING AND CHEST PAIN. OXYGEN SATURATION DROPPED ACUTELY DESPITE OXYGEN THERAPY; PATIENT WAS TRANSFERRED TO THE NEUROCRITICAL CARE UNIT FOR STABILIZATION. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT AS FOR THE TIMING OF THE PNEUMONIA, THE PATIENT HAD A CHEST X-RAY SHOWING NO PNEUMONIA AT 17:00 ON (B)(6) 2024. AT 13:26 ON (B)(6) AFTER THE TUBE WAS REMOVED, THE X-RAY SHOWED NEW PNEUMONIA IN THE LEFT LOWER LOBE, WHERE THE DOBHOFF HAD BEEN RECENTLY REMOVED. A CT CHEST DONE AT 20:00 ON THE 25TH ADDITIONALLY SHOWED A SMALL HYDROPNEUMOTHORAX IN THE LEFT LOWER LOBE AND NEEDED TO BE TRANSFERRED TO THEIR ICU FOR STABILIZATION. THE PATIENT WAS DISCHARGED AND HAS MISSED AN AMBULATORY APPOINTMENT, SO THE CUSTOMER HAS NO NEWS ON THE CURRENT STATUS OF THE PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2089686 CARDINAL HEALTH TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT CARDINAL HEALTH, INC. 8884721252E 10884521583030

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| H