BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARGYLE

    MDR report key: 11684776 · Received April 19, 2021

    Report

    Report Number
    11684776
    Event Type
    Injury
    Date Received
    April 19, 2021
    Date of Event
    April 5, 2021
    Report Date
    April 6, 2021
    Manufacturer
    CARDINAL HEALTH, INC.
    Product Code
    FOS
    UDI-DI
    20884527005175
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WHILE SUTURING A UMBILICAL CATHETER ARGYLE" VESSEL 3.5 FR. 15 INCH DUAL LUMEN, IT INADVERTENTLY BROKE AT 8 CM AND WAS UNABLE TO BE RETRIEVED. A CHEST X-RAY WAS IMMEDIATELY TAKEN AND THE LINE FRAGMENT WAS IN THE INFERIOR VENA CAVA. THE NEWBORN PATIENT WAS TRANSFERRED VIA LIFEFLIGHT TO A CHILDREN'S SPECIALTY HOSPITAL. THE NEWBORN PATIENT WAS TAKEN TO INTERVENTIONAL RADIOLOGY WHERE THEY WERE ABLE TO RETRIEVE THE FRAGMENT FROM THE LEFT PULMONARY ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587215 ARGYLE CATHETER, UMBILICAL ARTERY FOS CARDINAL HEALTH, INC. 8888160531 2011900052 20884527005175

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Other| R