BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEPARIN LOCK FLUSH

    MDR report key: 1162714 · Received September 15, 2008

    Report

    Report Number
    1162714
    Event Type
    Malfunction
    Date Received
    September 15, 2008
    Date of Event
    September 9, 2008
    Report Date
    September 15, 2008
    Manufacturer
    AMSINO MEDICAL USA
    Product Code
    NZW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RN WENT TO HEPARINIZE A PATIENT'S CENTRAL LINE AFTER IV PUSH MEDICATION. RN OBTAINED A PRE-PACKAGED HEPARIN FLUSH SYRINGE, ATTACHED TO THE CENTRAL LINE AND ATTEMPTED TO PUSH IN HEPARIN AND MET RESISTANCE IN THE LINE. RN D/CD THE SYRINGE FROM THE LINE TO DISCOVER THAT THE SYRINGE WAS EMPTY - SYRINGE DID NOT HAVE HEPARIN, BUT ONLY AIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEPARIN LOCK FLUSH SYRINGE, PRE-FILLED, HEPARIN NZW AMSINO MEDICAL USA 10UNITS/ML 3ML IN 12ML SYRINGE KH02749

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO NO OTHER THERAPIES| NO OTHER THERAPIES