BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Q2 MULTIPORT EXTENSION SET - 10 INCH

    MDR report key: 6169977 · Received December 13, 2016

    Report

    Report Number
    1649914-2016-00067
    Event Type
    Malfunction
    Date Received
    December 13, 2016
    Date of Event
    November 12, 2016
    Report Date
    January 5, 2017
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    FPA
    UDI-DI
    00634624952003
    PMA / PMN Number
    K151079
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ALLEGED COMPLAINT CONDITION COULD NOT BE DUPLICATED IN THE SAMPLE DEVICE NOR IN DEVICES FROM THE SAME LOT TESTED. IT IS POSSIBLE THAT THE CLINICIAN DID NOT PRIME THE SIDE PORTS FIRST THEN THE MAIN CENTRAL PORT.

    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

    THE PRODUCT DISTRIBUTOR REPORTED AN ISSUE ENCOUNTERED BY THE CLINICIAN WHILE USING THE INTRAVASCULAR ADMINISTRATION EXTENSION SET. THE REPORT DETAILS STATED THAT "AIR WAS ENTERING THRU DISTAL END OF MANIFOLD." FOLLOW-UP WITH THE COMPLAINANT FOUND THAT THERE WERE NO PATIENT COMPLICATIONS AND ANOTHER DEVICE WAS USED INSTEAD. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.``

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819992 Q2 MULTIPORT EXTENSION SET - 10 INCH INTRAVASCULAR ADMINISTRATION SET FPA QUEST MEDICAL, INC. 9520 0518216G06 00634624952003

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention