BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEPARIN 100 UNITS PER ML

    MDR report key: 1021515 · Received March 27, 2008

    Report

    Report Number
    MW5006050
    Event Type
    Injury
    Date Received
    March 27, 2008
    Date of Event
    March 20, 2008
    Report Date
    March 27, 2008
    Manufacturer
    MEDEFIL
    Product Code
    NZW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS SEEN IN MD OFFICE FOR ROUTINE FOLLOW UP, SHE HAD HER PORT ACCESSED AND FLUSHED SITE NS 10MLS AND HEP 100U/ML 5ML. LESS THAN 5 MINUTES AFTER PORT WAS FLUSHED THE PT STATED THAT SHE FELT LIGHTHEADED. THE PT FAINTED IN THE EXAM ROOM WHILE BEING ATTENDED TO BY RN. MD WAS IN EXAM ROOM IMMEDIATELY AFTER THIS OCCURRED. THE PT HAD NO BP, HR-40'S AND O2-92%. THE PT WAS TREATED WITH O2 AT 2 1PM, D5NS 1000MLS AND ATROPINE 0.3ML. BP AFTER ATROPINE 103/80, HR-80S. EMS TRANSPORTED THE PT FROM THE PHYSICIAN OFFICE TO THE ER. PATIENT SEEN IN ER WITH RIGHT FLANK PAIN, STERNAL CHEST PAIN AND SLIGHT SHORTNESS OF BREATH. PATIENT WAS ADMITTED FOR OBSERVATION, TELEMETRY MONITORING, CHECK SERIAL CARDIAC MARKERS, VQ SCAN TO RULE OUT PE B/C NO PERIPHERAL VENOUS ACCESS TO DO CT ANGIOGRAM. IMPRESSION- SYNCOPE, CHEST PAIN. DOSE OR AMOUNT: 500 UNITS, ROUTE: IV BOLUS. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: MAINTAIN PATENCY OF IMPLANTED PORT. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEPARIN 100 UNITS PER ML NONE NZW MEDEFIL H107317

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R