BEUDAMED
    FDA Adverse Event Death Summary report: N

    MONOJECT PREFILL ADVANCED

    MDR report key: 1180423 · Received September 29, 2008

    Report

    Report Number
    MW5008470
    Event Type
    Death
    Date Received
    September 29, 2008
    Date of Event
    October 31, 2007
    Report Date
    September 29, 2008
    Manufacturer
    TYCO HEALTHCARE GROUP LP
    Product Code
    NZW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    NOT SURE IF THIS LOT WAS RECALLED, BUT PRIOR TO DEATH PT WAS RECEIVING IN-HOME INTRAVENOUS ANTIBIOTIC THERAPIES AND HAD A PRE AND POST ADMINISTRATION FLUSH REGIMEN THAT INCLUDED 100 UNITS/ML HEPARIN LOCK FLUSH PACKAGED IN MONOJECT PREFILL ADVANCED 5ML FILL SYRINGES MARKETED BY TYCO HEALTHCARE UNDER THE KENDALL LABEL. NDC FOR THIS PRODUCT IS 17474-0125-5. PT USED MORE THAN 100 DOSES OF THIS MEDICATION IN THE MONTHS BEFORE HIS DEATH. OFFICIAL CAUSE OF DEATH WAS LISTED AS END STAGE PULMONARY. FAMILY STILL HAS A LARGE QUANTITY OF THIS PRODUCT ON HAND. DOSE OR AMOUNT: 20 ML; FREQUENCY: BID; ROUTE: IV BOLUS. DATES OF USE: THREE MONTHS IN 2007. DIAGNOSIS OR REASON FOR USE: ANTIBIOTIC REGIMEN IN-HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOJECT PREFILL ADVANCED HEPARIN LOCK FLUSH PREFILLED SYRINGE 5ML NZW TYCO HEALTHCARE GROUP LP 17474-0125-5 7072064

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death NONE AVAILABLE