BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Q2 CHECKMATE EXTENSION SET 44 INCH.

    MDR report key: 6368206 · Received March 1, 2017

    Report

    Report Number
    1649914-2017-00014
    Event Type
    Injury
    Date Received
    March 1, 2017
    Date of Event
    February 1, 2017
    Report Date
    February 1, 2017
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    FPK
    UDI-DI
    00634624095410
    PMA / PMN Number
    K800825
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    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

    THE NURSE REPORTED AN ISSUE OCCURRED WITH THE IV ADMINISTRATION EXTENSION SET DURING USE. SHE STATED THE SET LEAKED DURING USE. FOLLOW-UP WITH THE COMPLAINANT FOUND THAT THE TUBING WAS LOOSE AND THE CONNECTOR KEPT ROTATING; IT WAS NOT TIGHTENING. THE REPORT STATED THE PATIENT WAS HIV POSITIVE AND THE LEAK RESULTED IN A LARGE AMOUNT OF BLOOD ON THE FLOOR. THE LOT NUMBER WAS NOT PROVIDED. THE DEVICE WAS DISCARDED BY THE HOSPITAL AND WILL NOT RETURN FOR EVALUATION. ADDITIONAL FOLLOW-UP ATTEMPTS HAVE NOT BEEN SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152819 Q2 CHECKMATE EXTENSION SET 44 INCH. INTRAVASCULAR ADMINISTRATION EXTENSION SET FPK QUEST MEDICAL, INC. 9541 00634624095410

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention