BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN PREFILL

    MDR report key: 1853973 · Received September 29, 2010

    Report

    Report Number
    3002859087-2010-00150
    Event Type
    Malfunction
    Date Received
    September 29, 2010
    Date of Event
    December 1, 2007
    Report Date
    September 20, 2010
    Manufacturer
    COVIDIEN
    Product Code
    NZW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2010. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    ON (B)(6) 2010, COVIDIEN WAS INFORMED OF A CUSTOMER WHO HAD AN ISSUE WITH A HEPARIN PREFILLED SYRINGE. THE ATTORNEY ALLEGES THAT IN (B)(6) 2007 AND (B)(6) 2008, THE PT WAS ADMINISTERED HEPARIN WHILE AT HOME AND A HOSPITAL, AND EXPERIENCED, AMONG OTHER SYMPTOMS, DECREASED BLOOD PRESSURE, ABDOMINAL PAIN, AND NAUSEA. UPON INFO AND BELIEF, ON AT LEAST ONE OCCASION, THE HEPARIN ADMINISTERED TO THE PT WAS ALLEGED TO BE CONTAMINATED HEPARIN. SHORTLY THEREAFTER, THE PT BEGAN TO EXPERIENCE ADVERSE REACTIONS CONSISTENT WITH THE ADVERSE REACTIONS ASSOCIATED WITH CONTAMINATED HEPARIN.

    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