BEUDAMED
    FDA Adverse Event Death Summary report: N

    10FR 43 IRIS FEEDING TUBE ENF

    MDR report key: 8492548 · Received April 8, 2019

    Report

    Report Number
    1282497-2019-08364
    Event Type
    Death
    Date Received
    April 8, 2019
    Report Date
    April 8, 2019
    Manufacturer
    COVIDIEN
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT AT THIS TIME, NO FURTHER DETAILS HAVE BEEN PROVIDED. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. IF ADDITIONAL INFORMATION OR THE SAMPLE IS RECEIVED, THE INVESTIGATION WILL BE REOPENED AND RESPONDED TO ACCORDINGLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT THE AN IRIS TUBE WAS PLACED ON A PATIENT. THE PATIENT HEMORRHAGED AND THE PATIENT EXPIRED. ADDITIONAL INFORMATION RECEIVED FROM THE ASSISTANT NURSE MANAGER OF MICU ON (B)(6) 2019 STATED THAT THE PATIENT WAS AN (B)(6) MALE ON HEPARIN WITH SWALLOWING ISSUES AND A LOT OF SECRETIONS. A ¿SUPER USER¿ TRIED TO PLACE THE TUBE IN ONE NARE AND HIT RESISTANCE SO TRIED THE OTHER NARE. WHEN TRYING THE OTHER NARE THEY HIT RESISTANCE 3 TIMES AND THEN DECIDED TO STOP THE PLACEMENT. AFTER THIS FINAL ATTEMPT THEY NOTICED THE PATIENT BLEEDING. THE PATIENT HAD A DNR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284272 10FR 43 IRIS FEEDING TUBE ENF TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT COVIDIEN 461043E UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death