BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEPARIN LOCK FLUSH

    MDR report key: 1147665 · Received September 3, 2008

    Report

    Report Number
    MW5008190
    Event Type
    Malfunction
    Date Received
    September 3, 2008
    Report Date
    September 3, 2008
    Manufacturer
    EXCELSIOR MEDICAL
    Product Code
    NZW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    A HEPARIN FLUSH PRODUCT IS NOT LABELED APPROPRIATELY. THE HEPARIN FLUSH IS IN A SYRINGE LABELED ONLY WITH THE STRENGTH 100 UNITS PER ML. THAT IS, THE PACKAGING HAS NO INDICATION OF THE VOLUME IN THE SYRINGE WHICH IS 5ML! THE COMPANY IS EXCELSIOR MEDICAL, NEPTUNE NJ 07753 -800- 487- 4276. THE PACKAGE INSERT DESCRIPTION LISTS UNDER THE ''PRODUCT DESCRIPTION" SECTION: "EACH ... SYRINGE CONTAINS THE LABELED VOLUME ... OF HEPARIN LOCK FLUSH USP..." HOWEVER, NO VOLUME IS ON THE LABEL! IN LIGHT OF THE MANY ERRORS MADE WITH HEPARIN, AN UNFAMILIAR USER MIGHT EASILY ASSUME THAT THERE IS 100 UNITS OF HEPARIN IN THE SYRINGE. IN FACT, THERE ARE 500 UNITS IN 5ML. THE "HOW SUPPLIED" SECTION OF THE PACKAGE INSERT IS THE ONLY PLACE THAT REFERENCES THE VOLUME: 100 UNITS PER ML; 5 ML IN A 10 ML SYRINGE. INTERESTINGLY THE MARKINGS ON THE SYRINGE ONLY GO TO 5ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEPARIN LOCK FLUSH 100 UNITS PER ML NOT ON PACKAGE NZW EXCELSIOR MEDICAL 66-015-90

    Patients

    Seq Age Sex Outcome Treatment
    1