BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHECKMATE INTRAVASCULAR ADMINISTRATION SET

    MDR report key: 4211644 · Received October 29, 2014

    Report

    Report Number
    1649914-2014-00053
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    September 25, 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
    WV, 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. THIS REPORT STATED THAT WHILE THE DEVICE IS BEING REMOVED FROM THE STERILE PACKAGING, PART OF THE DEVICE DETACHES. IT WAS REPORTED THAT OCCASIONALLY THIS HAPPENS WHILE THE NURSE IS ATTEMPTING TO SPIKE THE IV BAG. THE REPORT STATED THAT THE DEVICE DETACHES AT THE LUER LOCK LOCATION. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED ISSUE. THE LOT NUMBER OF THE DEVICE WAS NOT NOTED BY THE HOSPITAL. ANY SAMPLE(S) WERE DISPOSED OF BY THE HOSPITAL AND NOT GIVEN TO THE MANUFACTUER FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691676 CHECKMATE INTRAVASCULAR ADMINISTRATION SET INTRAVASCULAR ADMINISTRATION SET FPK QUEST MEDICAL, INC. 9652

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention