BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNK PREFILL

    MDR report key: 1707027 · Received May 26, 2010

    Report

    Report Number
    3002859087-2010-00128
    Event Type
    Death
    Date Received
    May 26, 2010
    Report Date
    May 21, 2010
    Manufacturer
    COVIDIEN
    Product Code
    NZW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 05/21/2010, COVIDIEN WAS INFORMED OF A CUSTOMER WHO HAD AN ISSUE WITH A HEPARIN PREFILLED SYRINGE. THE ATTORNEY ALLEGES THAT THE PATIENT WAS ADMINISTERED HEPARIN WHILE ADMITTED IN THE HOSPITAL. UPON INFORMATION AND BELIEF, ON AT LEAST ONE OCCASION, THE HEPARIN ADMINISTERED TO THE PATIENT WAS ALLEGED TO BE CONTAMINATED HEPARIN. SHORTLY THEREAFTER, THE PATIENT BEGAN TO EXPERIENCE ADVERSE REACTIONS CONSISTENT WITH THE ADVERSE REACTIONS ASSOCIATED WITH CONTAMINATED HEPARIN. THE PATIENT PASSED ON (B) (6) 2008.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death