BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROWGARD BLUE PLUS

    MDR report key: 1844961 · Received September 9, 2010

    Report

    Report Number
    1844961
    Event Type
    Malfunction
    Date Received
    September 9, 2010
    Date of Event
    August 17, 2010
    Report Date
    August 31, 2010
    Manufacturer
    ARROW INTERNATIONAL
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US

    Narratives

    Description of Event or Problem · 1

    CATHETER HAD AN UNEXPECTED HYPEROPACITY ON X-RAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARROWGARD BLUE PLUS CENTRAL VENOUS CATHETER FOZ ARROW INTERNATIONAL UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR