BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1080825 · Received July 23, 2008

    Report

    Report Number
    3002859087-2008-00046
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    January 1, 2008
    Report Date
    July 16, 2008
    Manufacturer
    TYCO HEALTHCARE / KENDALL
    Product Code
    NZW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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

    IT WAS REPORTED TO TYCO HEALTHCARE/KENDALL THAT A CUSTOMER HAD AN ISSUE WITH A HEPARIN PREFILLED SYRINGE. THE CUSTOMER REPORTS INJECTED INTO A PORT A CATH. I HAD THIS PORT PUT IN IN 2007, BUT I HAD THE FIRST PORT PUT IN APPROX TWO MONTHS BEFORE. DATE OF EVENT IS QUESTIONABLE. I HAVE BEEN VERY SICK SINCE I STARTED USING. PORT TEST (BLOOD WORK) TWO TIMES IN THE SAME MONTH CAME BACK BOTH TIMES CONTAMINATED. I WAS RUSHED TO THE ER ON THE MONTH PRIOR TO ORIGINAL MONTH AND DISCHARGED ON FOUR DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 30327 12CC 100 UNIT HEP SYR {CAN} (5CC) HEPARIN PREFILLED SYRINGE NZW TYCO HEALTHCARE / KENDALL 8881590125 7072054

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization