BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN PREFILL

    MDR report key: 1516035 · Received October 20, 2009

    Report

    Report Number
    3002859087-2009-00043
    Event Type
    Death
    Date Received
    October 20, 2009
    Date of Event
    September 1, 2007
    Report Date
    September 28, 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

    SUBMIT DATE: 10/19/2009. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    ON 09/28/2009, COVIDIEN WAS INFORMED OF A CUSTOMER WHO HAD AN ISSUE WITH A HEPARIN PREFILLED SYRINGE. THE ATTORNEY ALLEGES THAT IN 2007, AN IV WAS INSERTED INTO THE PT THROUGH WHICH "HEPLOCK" WAS INSERTED INTO HIS BODY. THE PLAINTIFFS BELIEVE THE "HEPLOCK" WAS CONTAMINATED BY OVER-SULFATED CHONDROITIN SULFATE WHICH CAUSED REACTIONS IN THE PT INCLUDING A LOSS OF BP, HIGH FEVER, KIDNEY FAILURE, GI BLEEDING AND POSSIBLY OTHER PROBLEMS. DURING THE NEXT FEW DAYS, HE RECEIVED MORE HEPARIN DURING DIALYSIS UNTIL THERE WERE PHYSICIANS ORDERS TO D/C USE OF ANY HEPARIN PRODUCTS. THE PT DIED IN 2008.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death