BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1031062 · Received April 15, 2008

    Report

    Report Number
    3002859087-2008-00004
    Event Type
    Malfunction
    Date Received
    April 15, 2008
    Date of Event
    January 1, 2008
    Report Date
    March 21, 2008
    Manufacturer
    TYCO HEALTHCARE/KENDALL
    Product Code
    NZW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE 04/14/2008. AN INVESTIGATION IS CURRENTLY UNDERWAY, UPON COMPLETION THE RESULTS WILL BE FORWARDED. THESE REPORTS ARE BEING FILED IN ACCORDANCE TO THE APRIL 8TH FDA GUIDANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO TYCO HEALTHCARE/KENDALL ON 03/21/2008 THAT A CUSTOMER HAD A PROBLEM WITH THE PREFILLED HEPARIN SYRINGES. THE CUSTOMER REPORTS HOME INFUSION/CHEMO PT WITH A MEDIPORT. IMMEDIATELY AFTER UNHOOKING THE PT FROM CHEMO, THE LINE WAS FLUSHED WITH HEPARIN AND THE PT COMPLAINED OF NAUSEA. THE PT DID NOT VOMIT AND DID NOT REQUIRE ANY INTERVENTION.

    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 7072044

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK