BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT2® IV GRAVITY FLOW CONTROLLER, 20 DROPS/ML

    MDR report key: 2200009 · Received August 10, 2011

    Report

    Report Number
    3007305485-2011-00061
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Report Date
    August 9, 2011
    Manufacturer
    CONMED CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K905498A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE END-USER IN THIS EVENT DID NOT OBTAIN THE SUSPECT PRODUCT DIRECTLY FROM CONMED CORPORATION. THIS END-USER OBTAINED THE INVOLVED DEVICE THROUGH A DISTRIBUTOR, (B)(4). THE LOT NUMBER OF THE SUSPECT PRODUCT, 1010294, IS A LOT NUMBER THAT WAS PART OF A FIELD REMEDIAL ACTION FOR THE FAILURE MODE NOTED IN THIS EVENT. THIS FIELD REMEDIAL ACTION WAS REPORTED TO THE FDA IN APRIL 2011. THE DISTRIBUTOR, (B)(4), WAS NOTIFIED OF THE FIELD REMEDIAL ACTION INVOLVING THIS PRODUCT BY CONMED CORPORATION IN APRIL OF 2011. CONMED IS CONSIDERING THIS COMPLAINT CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED, "INFUSED 250 ML INTO PATIENT WITHIN ONE HOUR COULD NOT SET DIAL, THE UNIT STAYED WIDE OPEN AT ANY SETTING". THERE WAS NO REPORT OF ANY PATIENT INJURY ASSOCIATED WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAT2® IV GRAVITY FLOW CONTROLLER, 20 DROPS/ML STAT 2 IV CONTROLLER 20 DROP FPA CONMED CORPORATION 1010294

    Patients

    Seq Age Sex Outcome Treatment
    1