BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN PREFILL

    MDR report key: 1327703 · Received February 23, 2009

    Report

    Report Number
    3002859087-2009-00006
    Event Type
    Death
    Date Received
    February 23, 2009
    Date of Event
    December 1, 2007
    Report Date
    February 20, 2009
    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 FEBRUARY 20TH, 2009 COVIDIEN WAS INFORMED OF A CUSTOMER WHO HAD AN ISSUE WITH HEPARIN. THE ATTORNEY ALLEGES THAT THE PATIENT RECEIVED HEPARIN DURING A CARDIAC CATHETERIZATION PROCEDURE AND SUBSEQUENT HEART SURGERY IN 2007. SHORTLY THEREAFTER, THE PATIENT BEGAN TO EXPERIENCE SYMPTOMS CONSISTENT WITH THE ADVERSE REACTIONS ASSOCIATED WITH CONTAMINATED HEPARIN. UPON INFORMATION AND BELIEF, ON AT LEAST ONE OCCASION, THE HEPARIN ADMINISTERED TO PATIENT WAS A CONTAMINATED HEPARIN PRODUCT. THE PATIENT PASSED AWAY IN 2008.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death