BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Q2 MULTIPORT IV ADMINISTRATION SET

    MDR report key: 3252501 · Received July 25, 2013

    Report

    Report Number
    1649914-2013-00036
    Event Type
    Malfunction
    Date Received
    July 25, 2013
    Date of Event
    May 4, 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 REPORTED AN ISSUE WITH AN INTRAVENOUS ADMINISTRATION SET INCLUDING THE MODEL 9526B MULTIPORT MANIFOLD. THE NURSING STAFF REPORTED THAT THE PATIENT WAS RECEIVING MEDICATION (EITHER CHEMOTHERAPY OR FLUID ANTIBIOTICS) WHEN THE PATIENT NOTICED FLUID LEAKING AND DRIPPING ONTO THE FLOOR. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED EVENT. THE NURSE INSTALLED ANOTHER MANIFOLD SET AND THERAPY WAS CONTINUED. 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
    347354 Q2 MULTIPORT IV ADMINISTRATION SET INTRAVASCULAR ADMINISTRATION SET FPA QUEST MEDICAL, INC. 9526B

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention