BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDISYSTEMS

    MDR report key: 4558492 · Received February 21, 2015

    Report

    Report Number
    MW5040957
    Event Type
    Injury
    Date Received
    February 21, 2015
    Date of Event
    February 19, 2015
    Report Date
    February 19, 2015
    Manufacturer
    MEDISYSTEMS CORP.
    Product Code
    FIE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT CANNULATED WITHOUT INCIDENT WITH 15 GA FISTULA NEEDLES X 2 AND TAPED SECURELY PER SHC PROTOCOL. TWENTY THREE MINUTES INTO TREATMENT, STAFF NOTED BLOOD ON FLOOR BENEATH PATIENT'S CHAIR. FURTHER EXAM DETERMINED BLOOD WAS COMING FROM THE HUB OF THE VENOUS NEEDLE. PT REINFUSED AND GIVEN ADDITIONAL NS. DUE TO ALTERED LEVEL OF CONSCIOUSNESS, PT SENT VIA AMBULANCE TO LOCAL HOSPITAL FOR FURTHER EVALUATION AND TREATMENT. PT STABLE 4 HOURS AFTER INCIDENT BUT TO REMAIN FOR OVERNIGHT OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124320 MEDISYSTEMS FISTULA NEEDLE FIE MEDISYSTEMS CORP. D9-2005 MG 141013F6

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR