BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Q2 MULTIPORT IV ADMINISTRATION SET

    MDR report key: 3130131 · Received May 21, 2013

    Report

    Report Number
    1649914-2013-00027
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 25, 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

    REFERENCE: (B)(4). 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 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 AN ISSUE WITH AN INTRAVENOUS ADMINISTRATION SET INCLUDING THE MODEL 9526B MULTIPORT MANIFOLD. THE NURSING STAFF REPORTED THAT THE PT LEANED FORWARD IN THE HOSPITAL BED AND THE CHECK VALVE IN THE MANIFOLD DETACHED. THE MEDICATION BEING INFUSED WAS A CHEMOTHERAPY AGENT. THERE WERE NO PT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED EVENT. THE NURSE INSTALLED ANOTHER MANIFOLD SET AND THERAPY WAS CONTINUED. THE DEVICE LOT NUMBER WAS NOT KNOWN AND NOT PROVIDED, AND ADDITIONAL INFORMATION IS NOT AVAILABLE. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225471 Q2 MULTIPORT IV ADMINISTRATION SET INTRAVASCULAR ADMINISTRATION SET FPA QUEST MEDICAL, INC. 9526B

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention