BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN PREFILL

    MDR report key: 1486147 · Received August 24, 2009

    Report

    Report Number
    3002859087-2009-00035
    Event Type
    Death
    Date Received
    August 24, 2009
    Date of Event
    August 1, 2007
    Report Date
    August 21, 2009
    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. SUBMIT DATE: 9/16/2009.

    Description of Event or Problem · 1

    ON 08/21/2009, COVIDIEN WAS INFORMED OF A CUSTOMER WHO HAD AN ISSUE WITH A HEPARIN PREFILLED SYRINGE. THE ATTORNEY ALLEGES THAT THE PT WAS ADMINISTERED HEPARIN IN CONJUNCTION WITH TREATMENT OF END STAGE RENAL DISEASE. SHORTLY THEREAFTER, SHE BEGAN TO EXPERIENCE SYMPTOMS CONSISTENT WITH THE ADVERSE REACTIONS ASSOCIATED WITH CONTAMINATED HEPARIN. THE PT PASSED ON IN 2007.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death