BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAMBRO HEALTHCARE (COBE CARTRIDGE)

    MDR report key: 210142 · Received January 28, 1999

    Report

    Report Number
    210142
    Event Type
    Injury
    Date Received
    January 28, 1999
    Date of Event
    June 10, 1998
    Report Date
    January 27, 1999
    Manufacturer
    GAMBRO HEALTHCARE
    Product Code
    FJK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AFTER INJECTING (INFED 50 MG & EPOGEN 6000 UNITS) INTO VENOUS BLOOD LINE MEDICATION PORT & THEN REMOVING THE NEEDLES (27 GAUGE & 21 GAUGE) BLOOD POURED FROM THE INJECTION SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAMBRO HEALTHCARE (COBE CARTRIDGE) BLOOD LINES FJK GAMBRO HEALTHCARE * 81566N

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention