BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Q2 MULTIPORT IV ADMINISTRATION SET

    MDR report key: 3070581 · Received April 17, 2013

    Report

    Report Number
    1649914-2013-00015
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 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

    (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'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 HOSPITAL REPORTED AN ISSUE WITH AN INTRAVENOUS ADMINISTRATION SET INCLUDING THE MODEL 9526B MULTIPORT MANIFOLD. THE NURSING STAFF REPORTED THAT FOLLOWING PRIMING THE SET WITH SALINE, THE CENTER PORT OF THE MANIFOLD DETACHED. THEY REPORTED THERE WAS NO CONTACT/HANDLING OF THE PRODUCT AT THE TIME IT DETACHED. THERE WERE NO PT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED EVENT. THE DEVICE LOT NUMBER WAS NOT KNOWN AND NOT PROVIDED. THE DEVICE WAS RETURNED TO THE MFR FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164859 Q2 MULTIPORT IV ADMINISTRATION SET INTRAVASCULAR ADMINISTRATION SET FPA QUEST MEDICAL, INC. 9526B

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention