BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTISTAR 100X90" Y-TUBING

    MDR report key: 1051371 · Received May 16, 2008

    Report

    Report Number
    9610849-2008-00014
    Event Type
    Malfunction
    Date Received
    May 16, 2008
    Report Date
    April 21, 2005
    Manufacturer
    COVIDIEN
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LIEBEL FLARSHEIM MANUFACTURING REPORT: ALL OF OUR DISPOSABLE PRODUCTS ARE APPROVED FOR BIOCOMPATABILITY AND TISSUE CULTURE RESPONSES BEFORE THE PRODUCT IS INTRODUCED TO THE MARKET. IN THIS CASE, THE LE INJECTOR DISPOSABLE PRODUCTS INCLUDING PN801107 HAVE HAD NO DESIGN OR MATERIAL CHANGES SINCE BEING INTRODUCED IN 2000. WE HAVE NOT HAD ANY OCCASION OF A REPORT OF AN ALLERGIC RESPONSE WITH RESPECT TO THIS PRODUCT OR ANY DISPOSABLE PRODUCT IN OUR MANY YEARS OF MANUFACTURING EXPERIENCE. IF THERE ARE FURTHER INCIDENCE REPORTED OF THIS NATURE, AN INVESTIGATION WILL BE INITIATED.

    Description of Event or Problem · 1

    CUSTOMER DESCRIBES INCIDENT OF OPTIMARK REACTIONS. DURING CONVERSATION WITH CONTRAST MEDIA SPECIALIST, CUSTOMER STATED THAT THEY FELT THE REACTION WAS NOT DUE TO THE CONTRAST, BUT THE TUBING SYRINGE PRODUCT LINES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTISTAR 100X90" Y-TUBING EXTENSION TUBING DXT COVIDIEN "Y" TUBING 4331074

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK