BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1031060 · Received April 15, 2008

    Report

    Report Number
    3002859087-2008-00002
    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
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DAY 4/14/2008. 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 3/21/2008, THAT A CUSTOMER HAD A PROBLEM WITH THE PREFILLED HEPARIN SYRINGES. THE CUSTOMER REPORTS HOME INFUSION, CHEMO PATIENT WITH A MEDIPORT. IMMEDIATELY AFTER UNHOOKING THE CHEMO, THE LINE WAS FLUSHED WITH HEPARIN AND THE PATIENT INSTANTLY BEGAN VOMITING. THE PATIENT REQUIRED HOSPITALIZATION FOR IV FLUIDS AFTER BEING DIAGNOSED WITH DEHYDRATION.

    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 Hospitalization