BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1031065 · Received April 15, 2008

    Report

    Report Number
    3002859087-2008-00007
    Event Type
    Malfunction
    Date Received
    April 15, 2008
    Date of Event
    January 1, 2008
    Report Date
    April 7, 2008
    Manufacturer
    TYCO HEALTHCARE/KENDALL
    Product Code
    NZW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE 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 THAT A CUSTOMER HAD AN ISSUE WITH THE HEPARIN PREFILLED SYRINGE. THE CUSTOMER REPORTS, THAT SHE IS A HOME INFUSION PT AND THAT SHE HAS BEEN EXPERIENCING NAUSEA, VOMITING, DIARRHEA, FEVER AND CHILLS. SHE RECEIVES SALINE, HEPARIN AND ROCEPHIN IV AS STANDING ORDERS. HER MD SUGGESTED BLOODWORK FOR LFT'S.

    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 8010134

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK