BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Q2 CHECKMATE EXTENSION SET

    MDR report key: 4211576 · Received October 29, 2014

    Report

    Report Number
    1649914-2014-00051
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    September 23, 2014
    Report Date
    October 8, 2014
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    FPK
    PMA / PMN Number
    K800825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    QUEST MEDICAL, INC. HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. QUEST MEDICAL, INC. DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DURING A VISIT WITH THE HOSPITAL FACILITY, A QUEST MEDICAL REPRESENTATIVE WAS INFORMED OF SOME ISSUES WITH A FEW FLUID DELIVERY PRODUCTS. THE REPORT STATED THAT WHEN SYRINGES ARE ATTACHED TO THE FLUID DELIVERY DEVICE AND THE SET-UP IS BUMPED DURING A PROCEDURE, THE PORTS HAVE DETACHED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED ISSUE. THE LOT NUMBER OF THE DEVICE WAS NOT KNOWN. ANY SAMPLES WERE DISPOSED OF BY THE HOSPITAL AND NOT GIVEN TO THE MANUFACTURER FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692346 Q2 CHECKMATE EXTENSION SET INTRAVASCULAR ADMINISTRATION SET FPK QUEST MEDICAL, INC. 9546

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention