BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEPARIN I.V. FLUSH SYRINGE

    MDR report key: 1033402 · Received April 23, 2008

    Report

    Report Number
    MW5006378
    Event Type
    Injury
    Date Received
    April 23, 2008
    Date of Event
    April 11, 2008
    Report Date
    April 23, 2008
    Manufacturer
    MEDEFIL
    Product Code
    NZW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    HEPARIN 100 UNITS/ML; 3 ML PRE-FILLED SYRINGES BY MEDEFIL -LOT# H108118, H107332, H108106- WERE RECALLED BY MFR. THERE WERE REPORTS OF ADVERSE REACTIONS TO THE SPECIFIC LOTS SUCH AS LOW BLOOD PRESSURE, SHORTNESS OF BREATH, NAUSEA, VOMITING OR ABDOMINAL PAIN. PT'S FAMILY WAS CONTACTED ABOUT THIS AND NEW HEPARIN 100 UNITS/ML; 5 ML PRE-FILLED SYRINGES WERE SENT OUT TO THE HOME SAME DAY. MOM WAS INFORMED AND AWARE. MOM CALLED IN TO PHARMACY REGARDING PT'S OTHER MEDICATIONS AND MENTIONED THAT PT WAS HAVING NAUSEA, ABDOMINAL PAIN AND LOSS OF APPETITE WHICH RESOLVED AFTER SHE STOPPED USING RE-CALLED HEPARIN. MOM BELIEVES THAT PATIENT'S SYMPTOMS WERE RELATED TO HEPARIN AS THEY HAVE RESOLVED. NO PROBLEMS TO REPORT AT THIS TIME. MOM IS AWARE TO CONTACT PHARMACY IF OTHER PROBLEMS ARISE. MOM STATED, THAT SHE DISCUSSED PT'S SYMPTOMS WITH PT'S PHYSICIAN. DOSE OR AMOUNT: 3 ML, FREQUENCY: EVERY 8 HRS, ROUTE: IV. DATES OF USE: THIRTEEN DAYS IN 2008. DIAGNOSIS OR REASON FOR USE: MAINTENANCE OF PIC-LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEPARIN I.V. FLUSH SYRINGE NONE NZW MEDEFIL H108106

    Patients

    Seq Age Sex Outcome Treatment
    1