BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Q2 MULTIPORT MANIFOLD IV ADMINISTRATION SET

    MDR report key: 3098530 · Received April 23, 2013

    Report

    Report Number
    1649914-2013-00018
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 28, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). QUEST MEDICAL, INC. HAS LIMITED INFO RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT' 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 NURSING STAFF REPORTED AN ISSUE WITH AN INTRAVENOUS ADMINISTRATION SET INCLUDING THE MODEL 9527B MULTIPORT MANIFOLD. IT WAS REPORTED THAT WHILE THE SET WAS DELIVERING IV FLUIDS AND PRIOR TO THE CHEMOTHERAPY BEING ADDED, THE NURSE NOTICED A LEAK IN THE MANIFOLD AND FLUIDS DRIPPING TO THE FLOOR. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED EVENT. THE EXACT PRODUCT CODE OF THE DEVICE INVOLVED IS NOT KNOWN AT THIS TIME. IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED TO THE MANUFACTURER FOR ANALYSIS. NO ADDITIONAL INFORMATION IS KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174132 Q2 MULTIPORT MANIFOLD IV ADMINISTRATION SET INTRAVASCULAR ADMINISTRATION SET FPA QUEST MEDICAL, INC. 9526B OR 9527B

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention