BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDINAL HEALTH

    MDR report key: 22772713 · Received August 11, 2025

    Report

    Report Number
    1423537-2025-00316
    Event Type
    Injury
    Date Received
    August 11, 2025
    Report Date
    August 11, 2025
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    KNT
    UDI-DI
    10192253011159
    PMA / PMN Number
    K112511
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED AS NO LOT INFORMATION WAS PROVIDED WITHIN THE COMPLAINT. 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. AS SUCH, A ROOT CAUSE COULD NOT BE DETERMINED. WE WILL CONTINUE TO MONITOR RELATED REPORTS TO DETERMINE IF ADDITIONAL ACTIONS ARE NECESSARY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A CASE OF EXTREME DIFFICULTLY REMOVING THE DOBBHOFF TUBE WIRE WITH THE TUBE IN THE APPROPRIATE POSITION. IT WAS CONFIRMED THAT THE TUBE WAS FLUSHED AND THE WIRE WAS MOVING FREELY BEFORE INSERTION. CONFIRMED PROPER PLACEMENT ON XRAY WITH NO INDICATION OF ANY SHARP TURNS/KINKS WHICH WOULD HINDER WIRE REMOVAL. WHEN THE WIRE WAS ATTEMPTED TO BE REMOVED, IT REQUIRED EXTREME FORCE. THE TEAM REMOVED THE TUBE BEFORE TRYING TO USE FORCE TO REMOVE THE WIRE AND HAD THE SAME DIFFICULTLY WITH 3 DIFFERENT TUBES REQUIRING 3 DIFFERENT SETS OF XRAYS AND ULTIMATELY LEADING TO THE PATIENT HAVING BLOOD SECRETIONS/ASPIRATIONS LIKELY FROM TRAUMA DUE TO PROLONGED ATTEMPTED INSERTION. ULTIMATELY, THEY OBTAINED A 4TH TUBE FROM ANOTHER UNIT AND HAD SUCCESS. ADDITIONAL INFORMATION RECEIVED ON 23JUL2025 STATED THAT THE PATIENT ENDED UP HAVING HEMOPTYSIS AND ASPIRATION WITH HYPOXIA REQUIRING TRANSFER TO ICU. PATIENT RECEIVED INHALED TXA, HAD ENT PULL OUT CLOT. THE PATIENT ENDED UP NEEDING TO BE INTUBATED (THOUGH SHE ALSO HAD ISSUES WITH MENTAL STATUS AND ASPIRATED A TOOTH WHICH WAS UNRELATED). ULTIMATELY, SHE ENDED UP IN SEPTIC SHOCK. SHE DID NOT REQUIRE NASAL PACKING, BUT DID CONTINUE TO HAVE BLOODY SECRETIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2035261 CARDINAL HEALTH TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT CARDINAL HEALTH 200, LLC 8884710826E 10192253011159

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention