BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Q2 MULTIPORT IV ADMINISTRATION SET

    MDR report key: 3357876 · Received August 28, 2013

    Report

    Report Number
    1649914-2013-00048
    Event Type
    Malfunction
    Date Received
    August 28, 2013
    Date of Event
    August 1, 2013
    Report Date
    August 7, 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 SYS FOR THIS TYPE OF ALLEGED ISSUE. THIS SPECIFIC EVENT HAS BEEN INCLUDED IN THAT INVESTIGATION EVEN THOUGH THE DEVICE WS NOT RETURNED FOR ANALYSIS. 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 HOSP REPORTED AN ISSUE WITH AN INTRAVENOUS ADMINISTRATION SET INCLUDING THE MODEL 9526B MULTIPORT MANIFOLD. THE NURSING STAFF REPORTED THAT THE DEVICE HAD A FILTER LEAK. THERE WERE NO OTHER DETAILS PROVIDED REGARDING THE ALLEGED ISSUE. ATTEMPTS TO OBTAIN ADD'L INFO FROM THE FACILITY HAVE NOT BEEN SUCCESSFUL. THERE WERE NO PT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED EVENT. THE DEVICE WAS NOT RETURNED TO THE MFR FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421385 Q2 MULTIPORT IV ADMINISTRATION SET INTRAVASCULAR ADMINISTRATION SET FPA QUEST MEDICAL, INC. 9526B 043171

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention