BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET, ADMINISTRATION, INTRAVASCULAR

    MDR report key: 5963378 · Received September 20, 2016

    Report

    Report Number
    5963378
    Event Type
    Malfunction
    Date Received
    September 20, 2016
    Date of Event
    August 3, 2016
    Report Date
    August 19, 2016
    Manufacturer
    CAREFUSION 211, INC.. DBA CAREFUSION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HPC COLLECTION PHERESIS PROCEDURE WAS COMPLETED. WHEN ATTEMPTING TO REMOVE THE APHERESIS NEEDLE'S TUBING FROM THE EXTENSION SET, THE SCREW MECHANISM CAME LOOSE FROM IT'S ORIGINAL LOCATION AND WAS NOT FUNCTIONAL. AFTER NUMEROUS ATTEMPTS, ABLE TO REMOVE THE NEEDLE'S TUBING FROM THE EXTENSION SET WITH USE OF A TOURNIQUET FOR EXTRA TRACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616102 SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 211, INC.. DBA CAREFUSION MX9060 15126555

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR