BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1664623 · Received April 15, 2010

    Report

    Report Number
    3002859087-2010-00115
    Event Type
    Malfunction
    Date Received
    April 15, 2010
    Report Date
    April 12, 2010
    Manufacturer
    COVIDIEN
    Product Code
    NZW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). AN INVESTIGATION IS CURRENTLY UNDERWAY UPON COMPLETION THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    ON 04/12/2010, COVIDIEN WAS INFORMED OF A CUSTOMER WHO HAD AN ISSUE WITH A HEPARIN PREFILLED SYRINGE. AS REPORTED TO COVIDIEN BY ANOTHER MANUFACTURER, THE ATTORNEY ALLEGES THAT THE PATIENT DEVELOPED LOW PLATELET COUNTS, PAIN IN THE CHEST, WEAKNESS, CONFUSION, LOW BLOOD PRESSURE, ANGIOEDEMA, SHORTNESS OF BREATH, NAUSEA, DIARRHEA, AND ABDOMINAL PAIN AFTER HEPARIN FLUSH SOLUTION FROM LOT 7113034 WAS ADMINISTERED INTRAVENOUSLY THROUGH A PICC LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 30327 12CC 100 UNIT HEP SYR {CAN} (5CC) HEPARIN PREFILL NZW COVIDIEN 8881590125 7113034

    Patients

    Seq Age Sex Outcome Treatment
    1