BEUDAMED
    FDA Adverse Event Other Summary report: N

    ASPIRATION TUBING SET

    MDR report key: 2303758 · Received October 4, 2011

    Report

    Report Number
    1450997-2011-00001
    Event Type
    Other
    Date Received
    October 4, 2011
    Date of Event
    July 8, 2011
    Report Date
    October 3, 2011
    Manufacturer
    NORTHGATE TECHNOLOGIES, INC.
    Product Code
    KQT
    PMA / PMN Number
    K921451
    Removal / Correction Number
    1450997-8/4/11-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PIECE OF 10' TUBING THAT HAS THE RED FLAG ASSEMBLED TO IT NOW HAS A RED STRIPE THE ENTIRE LENGTH OF THE 10' ASSEMBLY OPERATIONS SHALL ASSEMBLE THE RED FLAG TO THAT LENGTH OF TUBING AND ONLY THAT LENGTH OF TUBING. THE TUBING SHALL BE WRAPPED AND INSERTED INTO A TYVEK POUCH WITH THE 10' PIECE OF UNSTRIPED TUBING ON THE BOTTOM AND THE 10' STRIPED TUBING ON THE TOP - THIS WAY YOU CAN ALWAYS TELL IF THE RED FLAG IS ASSEMBLED TO THE CORRECT PIECE OF 10' TUBING. IN ADDITION, THE IFU HAS BEEN IMPROVED GREATLY TO INCLUDE BETTER GRAPHICS SUCH AS THE "FLOW," "RED FLAG," AND THE PIECE OF 10' TUBING THAT ILLUSTRATES THE RED STRIPE. ALSO, THE IFU SHALL BE INCLUDED IN EACH TYVEK POUCH.

    Description of Event or Problem · 1

    CUSTOMER STATES, (B)(6) 2011 OUT OF BOX FAILURE. THE FIRST TUBING SET BROKE IN THE NURSES HAND, THE NEXT FOUR (4) HAD THE RED TAG ON THE WRONG END AND WHEN THEY USE BY TURNING IT AROUND IT IS A DANGER TO THE PATIENT PER THE DOCTOR. THEY WILL HAVE TO USE A COUPLE THAT WAY AS THIS ITEM IS ON BACK ORDER AND THEY HAVE CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASPIRATION TUBING SET FLUID ASPIRATION TUBING SET KQT NORTHGATE TECHNOLOGIES, INC. 72-00114-D NW9527

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other