BEUDAMED
    FDA Adverse Event Death Summary report: N

    MW5060195

    MDR report key: 5440585 · Received February 12, 2016

    Report

    Report Number
    MW5060195
    Event Type
    Death
    Date Received
    February 12, 2016
    Date of Event
    January 28, 2016
    Report Date
    February 5, 2016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    2

    Narratives

    Description of Event or Problem · 1

    MANIFOLD WAS PREPARED IN THE USUAL FASHION, CONNECTIONS CHECKED AND CONTRAST WAS PRIMED. AFTER TIG CATHETER INSERTION, MANIFOLD WAS CONNECTED BY MD AND FLUSHED. TWO PICTURES WERE TAKEN AND ON THE THIRD PICTURE IT WAS NOTED THAT THERE WAS AIR EMBOLI IN THE CIRCUMFLEX.. THE PATIENT RAPIDLY DECOMPENSATED ANGIODYNAMICS SUPPLIES THE MANIFOLD TO CARDINAL FOR ASSEMBLY, AND THEN RE-PACKED IN THE INFORMATION PROVIDED. ANGIODYNAMICS INFORMATION IS LOT 4924376 WITH CATALOG NUMBER 651800217 WITH EXPIRATION DATE OF 05/01/2018.

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death