BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN PREFILL

    MDR report key: 1562844 · Received December 16, 2009

    Report

    Report Number
    3002859087-2009-00081
    Event Type
    Death
    Date Received
    December 16, 2009
    Date of Event
    September 1, 2007
    Report Date
    November 19, 2009
    Manufacturer
    COVIDIEN
    Product Code
    NZW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 NOVEMBER 19, 2009, COVIDIEN WAS INFORMED OF A CUSTOMER WHO HAD AN ISSUE WITH A HEPARIN PREFILLED SYRINGE. THE ATTORNEY ALLEGES THAT THE PATIENT RECEIVED HEPARIN, (WHILE AT HOME AND WHILE HOSPITALIZED) AS PART OF A THERAPEUTIC TREATMENT IN 2007. WHILE HOSPITALIZED, THE PATIENT RECEIVED HEPARIN IN THE FORM OF BOTH SINGLE AND MULTI DOSE VIALS. WHILE HOME, THE PATIENT RECEIVED HEPARIN IN THE FORM OF A MONOJECT HEP-LOCK FLUSH SYRINGE IN ORDER TO MAINTAIN A CLEAN ACCESS IN HIS PICC LINE AND PORT. DURING THE ADMINISTRATION OF THE HEPARIN, THE PATIENT EXPERIENCED SYMPTOMS CONSISTENT WITH FDA WARNINGS INCLUDING BUT NOT LIMITED TO ITCHING, REDNESS IN THE FACE, DROP IN PLATELET COUNT, CHEST PAIN, FATIGUE, DECREASED BLOOD PRESSURE, ABDOMINAL PAIN, N/V, THROAT SWELLING AND HEADACHE. THE PATIENT PASSED IN 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 UNK Death