BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN PREFILL

    MDR report key: 1062435 · Received June 17, 2008

    Report

    Report Number
    3002859087-2008-00026
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Date of Event
    January 1, 2008
    Report Date
    June 13, 2008
    Manufacturer
    TYCO HEALTHCARE/KENDALL
    Product Code
    NZW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHARMACIST

    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 A PROBLEM WITH A PREFILLED SYRINGE. THE CUSTOMER REPORTS THAT THE PT REPORTED CHILLS AND LOW GRADE FEVER IMMEDIATELY AFTER FLUSHING PORT WITH HEPARIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN PREFILL PREFILL SYRINGE NZW TYCO HEALTHCARE/KENDALL UNKNOWN PREFILL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN