BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN PREFILL

    MDR report key: 1624133 · Received March 4, 2010

    Report

    Report Number
    3002859087-2010-00089
    Event Type
    Death
    Date Received
    March 4, 2010
    Date of Event
    September 1, 2007
    Report Date
    February 22, 2010
    Manufacturer
    COVIDIEN
    Product Code
    NZW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. THE ATTORNEY ALLEGES THAT THE PATIENT WAS ADMINISTERED HEPARIN DURING A DIALYSIS PROCEDURE OR PROCEDURES, AND POSSIBLY OTHER PROCEDURES, IN (B) (6) 2007 . SHORTLY THEREAFTER, THE PATIENT BEGAN TO EXPERIENCE SYMPTOMS CONSISTENT WITH HYPERSENSITIVITY-TYPE ADVERSE REACTIONS ASSOCIATED WITH CONTAMINATED HEPARIN. THE ATTORNEY ALLEGES THE PATIENT EXPERIENCED SYMPTOMS INCLUDING, BUT NOT LIMITED TO, DECREASED BLOOD PRESSURE, FAINTING, SWELLING OF THE THROAT, AND ORGAN FAILURE RESULTING IN A HOSPITALIZATION OF APPROXIMATELY FIVE TO SIX DAYS. UPON INFORMATION AND BELIEF, THE HEPARIN ADMINISTERED TO THE PATIENT WAS ALLEGED TO BE CONTAMINATED HEPARIN. THE PATIENT PASSED 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 UNKNOWN Death