BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDEFIL

    MDR report key: 1052155 · Received May 23, 2008

    Report

    Report Number
    MW5007032
    Event Type
    Injury
    Date Received
    May 23, 2008
    Date of Event
    March 28, 2008
    Report Date
    May 23, 2008
    Manufacturer
    MEDEFIL
    Product Code
    NZW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NOTIFIED 5/21/2008 OF PT/PTS. DAUGHTER STILL HAVE LARGE SUPPLY OF HEPARIN FLUSH AT HOME. FAMILY/PHYSICIAN CONCERN IF RECENT HOSPITALIZATIONS ARE RELATED TO HEPARIN CONTAMINANT (POSSIBLE). HEPARIN 500 UNITS GIVEN PRN AT HOME LINE PATENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDEFIL HEPARIN FLUSH 100 U/CC NZW MEDEFIL H107301 (35)
    2 MEDEFIL HEPARIN FLUSH 100U/CC NZW MEDEFIL H107309 60
    3 MEDEFIL HEPARIN FLUSH 100U/CC NZW MEDEFIL H106366 2

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization