BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNK PREFILL

    MDR report key: 1353713 · Received March 30, 2009

    Report

    Report Number
    3002859087-2009-00013
    Event Type
    Death
    Date Received
    March 30, 2009
    Date of Event
    January 1, 2007
    Report Date
    March 26, 2009
    Manufacturer
    COVIDIEN
    Product Code
    NZW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL LOT NUMBER: 8010124. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED. THE COMPLAINT REFERENCES 1 RECALLED LOT NUMBER (8010174) AND A 2ND LOT NUMBER (8010124) THAT WAS NOT INVOLVED IN THE RECALL. THE SECOND LOT NUMBER (8010124) WAS TESTED AND FOUND TO BE FREE OF OSCS.

    Description of Event or Problem · 1

    IN 2009, COVIDIEN WAS INFORMED OF A CUSTOMER WHO HAD AN ISSUE WITH A HEPARIN PREFILLED SYRINGE. THE ATTORNEY ALLEGES THAT THE PATIENT RECEIVED IV HEPARIN-LOCK FLUSH THERAPY (LOT 8010174 AND 8010124) FROM 2007 THROUGH 2008. THE PATIENT EXPERIENCED EXCESSIVE SWEATING, BLURRED VISION, SHORTNESS OR BREATH, THROWING UP BLOOD, LOW BLOOD PRESSURE AND DEATH. THE PATIENT DIED IN 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK PREFILL HEPARIN PREFILL NZW COVIDIEN UNK PREFILL 8010174

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death