BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Q2 MULTIPORT ADMINISTRATION SET

    MDR report key: 3371575 · Received September 6, 2013

    Report

    Report Number
    1649914-2013-00047
    Event Type
    Malfunction
    Date Received
    September 6, 2013
    Date of Event
    August 1, 2013
    Report Date
    August 13, 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 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'S PEDIATRIC FLOOR RN REPORTED THAT WHILE ADJUSTING A SET WHICH INCLUDED THE Q2 MULTIPORT MANIFOLD, THE NURSE ENCOUNTERED AN ISSUE. THE NURSE REPORTED THAT THE TUBING DETACHED FROM THE SET JUST ABOVE THE CHECKVALVE AS SHE WAS USING THE HIGHEST "Y SITE" ON THE SET. IT WAS REPORTED THAT THE PT WAS A CHILD RECEIVING PAIN MEDICATION (MORPHINE) AT THE TIME OF THE ALLEGED EVENT. THERE WERE NO PT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED EVENT. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION BUT THE LOT INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443920 Q2 MULTIPORT ADMINISTRATION SET INTRAVASCULAR ADMINISTRATION SET FPA QUEST MEDICAL, INC. 9525A 041200

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention