BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Q2 MULTIPORT MANIFOLD IV ADMINISTRATION SET

    MDR report key: 3264778 · Received July 31, 2013

    Report

    Report Number
    1649914-2013-00042
    Event Type
    Malfunction
    Date Received
    July 31, 2013
    Date of Event
    July 3, 2013
    Report Date
    July 3, 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. THE INVESTIGATION THUS FAR HAS IDENTIFIED SEVERAL MINOR IMPROVEMENTS AND ADJUSTMENTS TO INCREASE PROCESS ROBUSTNESS. QUEST MEDICAL, INC. HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. QUEST MEDICAL, INC. DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT WHILE PRIMING A SET WHICH INCLUDED THE Q2 MULTIPORT MANIFOLD, THE NURSE NOTICED THE SET WAS LEAKING. THE SET WAS NOT CONNECTED TO THE PT AT THE TIME; THIS WAS PRIOR TO USE ON A PT. THE DEVICE WAS RETURNED TO THE MFR FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358146 Q2 MULTIPORT MANIFOLD IV ADMINISTRATION SET INTRAVASCULAR ADMINISTRATION SET FPA QUEST MEDICAL, INC. 9527B

    Patients

    Seq Age Sex Outcome Treatment
    1