BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    30327 3CC 100 UNIT HEP SYR {CAN} (2.5CC)

    MDR report key: 1033756 · Received April 23, 2008

    Report

    Report Number
    3002859087-2008-00013
    Event Type
    Malfunction
    Date Received
    April 23, 2008
    Report Date
    April 18, 2008
    Manufacturer
    TYCO HEALTHCARE/KENDALL
    Product Code
    NZW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE 4/23/2008. 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 ON 04/18/2008 THAT A CUSTOMER HAD A PROBLEM WITH THE HEPARIN PREFILLED SYRINGES. THE CUSTOMER REPORTS, "I'VE HAD 2 SERIOUS ALLERGIC REACTIONS TO THE HEPARIN YOU SELL".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 30327 3CC 100 UNIT HEP SYR {CAN} (2.5CC) HEPARIN PREFILLED SYRINGE NZW TYCO HEALTHCARE/KENDALL 8881590300 8010114

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK