BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARROWGARD BLUE PLUS

    MDR report key: 2010431 · Received March 2, 2011

    Report

    Report Number
    MW5019663
    Event Type
    Injury
    Date Received
    March 2, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 2, 2011
    Manufacturer
    ARROW INTERNATIONAL
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN ATTEMPTED TO INSERT MULTI-LUMEN CVC AND THE GUIDEWIRE WOULD NOT ADVANCE. SAME ISSUE OCCURRED WITH PRESSURE INJECTABLE MULTI-LUMEN CVC CATH KIT LOT #RF0117127.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARROWGARD BLUE PLUS PRESSURE INJECTABLE CVC DQO ARROW INTERNATIONAL CDC-42703-P1A RF0117127
    2 ARROWGARD BLUE PLUS PRESSURE INJECTABLE CVC DQO ARROW INTL RF0128563

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Disability