BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Q2 MULTIPORT MANIFOLD EXTENSION LINE

    MDR report key: 2997209 · Received March 5, 2013

    Report

    Report Number
    1649914-2013-00009
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 13, 2013
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    FPA
    PMA / PMN Number
    K040385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE 5 OF 5. 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

    REFERENCE: 1649914-2013-00004.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93736 Q2 MULTIPORT MANIFOLD EXTENSION LINE IV EXTENSION TUBING KITS FPA QUEST MEDICAL, INC. 9520

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention