BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEPARIN FLUSH 100 UNITS/CC

    MDR report key: 1020011 · Received March 26, 2008

    Report

    Report Number
    MW5006039
    Event Type
    Injury
    Date Received
    March 26, 2008
    Date of Event
    March 13, 2008
    Report Date
    March 26, 2008
    Manufacturer
    MEDEFIL, INC
    Product Code
    NZW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD BROVIAC VAD AND ADMITTED FOR ACINETOBACTER -GRAM NEGATIVE ROD- BACTEREMIA. WE LATER DISCOVERED THAT THE HEPARIN FLUSHES THAT WERE USED WERE PART OF A RECALL. DOSE OR AMOUNT: 3CC, FREQUENCY: QDAY, ROUTE: IV BOLUS. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: INDWELLING VAD -BROVIAC-.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEPARIN FLUSH 100 UNITS/CC NONE NZW MEDEFIL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO Hospitalization