BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Q2 MULTIPORT MANIFOLD IV ADMINISTRATION SET

    MDR report key: 3252538 · Received July 25, 2013

    Report

    Report Number
    1649914-2013-00038
    Event Type
    Malfunction
    Date Received
    July 25, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 26, 2013
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    FPA
    PMA / PMN Number
    K040385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). QUEST MEDICAL, INC HAS INITIATED AN INVESTIGATION THROUGH THE CAPA SYSTEM FOR THIS TYPE OF ALLEGED ISSUE. THIS SPECIFIC EVENT HAS BEEN INCLUDED IN THAT INVESTIGATION EVEN THOUGH THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE INVESTIGATION THUS FAR HAS IDENTIFIED SEVERAL MINOR IMPROVEMENTS AND ADJUSTMENTS TO INCREASE PROCESS ROBUSTNESS. 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 HOSPITAL'S (B)(6) LOCATION REPORTED AN ISSUE WITH AN INTRAVENOUS ADMINISTRATION SET INCLUDING THE MODEL 9527B MULTIPORT MANIFOLD. THE NURSING STAFF REPORTED THAT THE DEVICE WAS LEAKING AT THE FILTER. THERE WAS NO INDICATION OF WHAT MEDICATION WAS BEING ADMINISTERED AT THE TIME THE ALLEGED ISSUE WAS NOTICED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED EVENT. THE DEVICE LOT NUMBER WAS NOT KNOWN AND NOT PROVIDED, AND ADDITIONAL INFORMATION IS NOT AVAILABLE. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347994 Q2 MULTIPORT MANIFOLD IV ADMINISTRATION SET INTRAVASCULAR ADMINSTRATION SET FPA QUEST MEDICAL, INC. 9527B

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention