BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    30327 12CC 10 UNIT HEP SYR {CAN} (5CC)

    MDR report key: 1053075 · Received May 28, 2008

    Report

    Report Number
    3002859087-2008-00020
    Event Type
    Malfunction
    Date Received
    May 28, 2008
    Report Date
    May 20, 2008
    Manufacturer
    TYCO HEALTHCARE/KENDALL
    Product Code
    NZW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IN 2008, TYCO HEALTHCARE/KENDALL WAS NOTIFIED THAT A CUSTOMER ALLEGES HE HAD A "SEVERELY PAINFUL REACTION" FROM A HEPARIN PREFILLED SYRINGE BY THE CUSTOMER'S ATTORNEY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 30327 12CC 10 UNIT HEP SYR {CAN} (5CC) PREFILL SYRINGE NZW TYCO HEALTHCARE/KENDALL 8881580125 7113174

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK