BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEPARIN PREFILLED SYRINGE 1:100

    MDR report key: 1053884 · Received May 28, 2008

    Report

    Report Number
    MW5007054
    Event Type
    Death
    Date Received
    May 28, 2008
    Date of Event
    February 6, 2008
    Report Date
    May 28, 2008
    Manufacturer
    COVIDIEN
    Product Code
    NZW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PATIENT WITH A PMH OF MYELOMA RECEIVED SEVERAL HEPARIN INJECTIONS -HEPARIN HEP-LOCK SOLUTION 1:100 5CC SYRINGES-. HE PRESENTED TO ER WITH SOB AND LOC. HE WAS ADMITTED TO THE HOSPITAL IN 2008. HE HAD HYPOTENSION, SEVERE DIARRHEA AND N/V, CHILLS, AND SEPSIS. HE DIED ON FOUR DAYS LATER. DOSE OR AMOUNT: ONE SYRINGE, FREQUENCY: Q8H, ROUTE: IV. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: LINE CLEARANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEPARIN PREFILLED SYRINGE 1:100 NONE NZW COVIDIEN NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death