BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARROWG+ARD

    MDR report key: 17371641 · Received July 19, 2023

    Report

    Report Number
    MW5119772
    Event Type
    Injury
    Date Received
    July 19, 2023
    Date of Event
    May 15, 2023
    Report Date
    July 14, 2023
    Manufacturer
    TELEFLEX / TELEFLEX LLC (NADC 2)
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SD, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THERE WAS AN ISSUE WITH CLEVIPREX RUNNING THROUGH THE WHITE PORT OF AN 8F SWAN BACKING UP INTO THE BROWN PORT OF THE 9F DOUBLE IJ/CORDIS. DOPAMINE WAS IN LINE/HOOKED UP TO THE BROWN PORT, BUT NOT RUNNING. IT WAS NOTED THAT THERE WAS A BACK UP OF WHITE IN THAT LINE, AND WAS ASSUMED IT WAS LIKELY CLEVIPREX. SECUREMENT OF THE CAP WAS DOUBLE CHECKED. THE EPI/CLEVIPREX WAS PULLED BACK AND THERE WAS GOOD BLOOD RETURN, AND THE LINE FLUSHED THROUGH WITH NO RESISTANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771850 ARROWG+ARD CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ TELEFLEX / TELEFLEX LLC (NADC 2) 13F22M0539

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Required Intervention ARROWG+ARD BLUE MAC TWO LUMEN CENTRAL VENOUS ACCESS FOR USE WITH 7.5-8, (B)(6) 2023 - (B)(6) 2023