BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN PREFILL

    MDR report key: 1611062 · Received February 16, 2010

    Report

    Report Number
    3002859087-2010-00047
    Event Type
    Death
    Date Received
    February 16, 2010
    Date of Event
    January 1, 2008
    Report Date
    January 21, 2010
    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.

    Description of Event or Problem · 1

    ON 01/21/10, COVIDIEN WAS INFORMED OF A CUSTOMER WHO HAD AN ISSUE WITH A HEPARIN PREFILLED SYRINGE. THE ATTORNEY ALLEGES THAT IN (B) (6) 2008, THE PATIENT WAS ADMINISTERED HEPARIN DURING HEART SURGERY. 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 UNKNOWN PREFILL HEPARIN PREFILL NZW COVIDIEN UNK PREFILL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death