BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN PREFILL

    MDR report key: 1624137 · Received March 4, 2010

    Report

    Report Number
    3002859087-2010-00085
    Event Type
    Death
    Date Received
    March 4, 2010
    Date of Event
    January 1, 2007
    Report Date
    February 19, 2010
    Manufacturer
    COVIDIEN
    Product Code
    NZW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    ON (B) (6) 2010 COVIDIEN WAS INFORMED OF A CUSTOMER WHO HAD AN ISSUE WITH A HEPARIN PREFILLED SYRINGE. AS REPORTED TO COVIDIEN BY (B) (6), THE ATTORNEY ALLEGES THAT ON (B) (6) 2007, THE PATIENT RECEIVED HEPARIN SODIUM AS PART OF A THERAPEUTIC TREATMENT. DURING HIS HOSPITALIZATION, THE PATIENT RECEIVED HEPARIN SODIUM SINGLE-DOSE AND MULTI-DOSE VIALS (WHICH IS NOT COVIDIEN MANUFACTURED PRODUCT). WHILE AT HOME, THE PATIENT RECEIVED HEPARIN SODIUM PRE-FILLED SYRINGES, MONOJECT HEP-LOCK FLUSH SYRINGES, TO MAINTAIN CLEAN ACCESS IN A PICC LINE AND PORT. IN 2007, DURING THE ADMINISTRATION OF HEPARIN SODIUM, THE PATIENT EXPERIENCED ITCHING, REDNESS IN THE FACE, DROP IN PLATELET COUNT, CHEST PAIN, FATIGUE, DECREASED BLOOD PRESSURE, ABDOMINAL PAIN, NAUSEA, VOMITING, THROAT SWELLING AND HEADACHES. TREATMENT AND OUTCOME FOR THE EVENTS WERE NOT REPORTED. THE PATIENT PASSES ON (B) (6) 2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN PREFILL HEPARIN PREFILL NZW COVIDIEN UNKNOWN PREFILL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death