BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL STRAIGHT SET 2Y MLL

    MDR report key: 984853 · Received December 28, 2007

    Report

    Report Number
    984853
    Event Type
    Malfunction
    Date Received
    December 28, 2007
    Date of Event
    December 17, 2007
    Report Date
    December 27, 2007
    Manufacturer
    SMITHS MEDICAL
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHEN DRIP CHAMBER IN THE TUBING IS EMPTIED, THE FLOATING BALL THAT IS SUPPOSED TO OCCLUDE THE TUBING OUTFLOW IN THE DRIP CHAMBER FALLS TO BOTTOM OF DRIP CHAMBER, BUT DOES NOT OCCLUDE THE TUBING OUTLET AS IT IS DESIGNED. THIS MALFUNCTION ALLOWS AIR TO ENTER THE TUBING, EVENTUALLY REACHING THE PUMP SEGMENT OF THE TUBING, AND SETTING OFF THE "AIR IN LINE" ALARM. THIS HAS HAPPENED AT LEAST FIVE TIMES (IN ADDITION TO PREVIOUSLY REPORTED EVENTS) AND INCLUDES DIFFERENT LOT NUMBERS, SPECIFICALLY LOT NUMBER 1153914 AND 1180838. MANUFACTURER WAS NOTIFIED THAT ONE OF THE DEFECTIVE TUBING IS AVAILABLE TO PICK UP FOR EXAMINATION, BUT NO OTHER FEEDBACK HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL STRAIGHT SET 2Y MLL TUBING, IV FPA SMITHS MEDICAL FB1L03 1180838

    Patients

    Seq Age Sex Outcome Treatment
    1 *