BEUDAMED
    FDA Adverse Event Death Summary report: N

    30327 12CC 100 UNIT HEP SYR {CAN} (5CC)

    MDR report key: 1672525 · Received April 29, 2010

    Report

    Report Number
    3002859087-2010-00121
    Event Type
    Death
    Date Received
    April 29, 2010
    Date of Event
    February 1, 2008
    Report Date
    April 26, 2010
    Manufacturer
    COVIDIEN
    Product Code
    NZW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 04.26.10, COVIDIEN WAS INFORMED OF A CUSTOMER WHO HAD AN ISSUE WITH A SO CALLED HEPARIN FINISHED PRODUCT. THE ATTORNEY ALLEGES THAT THE PATIENT WAS ADMINISTERED HEPARIN CONTAINING ALLEGED CONTAMINANTS FROM PREFILLED SYRINGES ON ONE OR MORE OCCASIONS, ON AND PRIOR TO (B) (6) 2008. THE PATIENT PASSED ON (B) (6) 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 30327 12CC 100 UNIT HEP SYR {CAN} (5CC) HEPARIN PREFILL NZW COVIDIEN 8881590125 7113104

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death