BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-REFLEC Y-SET 8"

    MDR report key: 1802481 · Received August 17, 2010

    Report

    Report Number
    6000001-2010-02535
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    July 7, 2010
    Report Date
    July 20, 2010
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    ---
    PMA / PMN Number
    K840760
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE AVAILABILITY IS UNKNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) THAT THE Y-SITE OF AN ANTI-REFLEC Y-SET THAT OF THE IS CRACKING, CAUSING THE SET TO LEAK. THE PROCESS WAS DURING USE ON PATIENT, BUT THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 4 OF 12 OF THE SAME REPORTED PROBLEM FROM THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-REFLEC Y-SET 8" SET, ADMINISTRATION, INTRAVASCULAR --- BAXTER HEALTHCARE R09J17054

    Patients

    Seq Age Sex Outcome Treatment
    1