BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Q2 MULTIPORT MANIFOLD EXTENSION LINE

    MDR report key: 3111755 · Received May 7, 2013

    Report

    Report Number
    1649914-2013-00023
    Event Type
    Malfunction
    Date Received
    May 7, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 10, 2013
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    FPA
    PMA / PMN Number
    K040385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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

    IT WAS REPORTED BY THE HOSP NURSING PERSONNEL THAT THEY EXPERIENCED AN ISSUE WITH THREE OF THE MODEL 9520 MANIFOLD EXTENSION LINES. THEY REPORTED THAT IN EACH INSTANCE, WHILE ATTACHING THE MANIFOLD TO ADD'L TUBING THE PORTS DETACHED FROM THE MANIFOLD. THERE WERE NO RESULTANT PT COMPLICATIONS FROM ANY OF THE ALLEGED ISSUES REPORTED. THE MANIFOLDS HAD ANTIBIOTICS IN THEM AT THE TIME OF THE ALLEGED EVENT. THE HOSP STATED THE ALL OF THE MANIFOLDS CAME FROM THE SAME LOT, BUT HAVE NOT PROVIDED LOT INFO AT THIS TIME. IT WAS REPORTED THAT ONE SAMPLE HAD BLOOD CONTACT AND WOULD NOT BE RETURNED FOR ANALYSIS. NO ADD'L INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197930 Q2 MULTIPORT MANIFOLD EXTENSION LINE IV EXTENSION TUBING KITS FPA QUEST MEDICAL, INC. 9520

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention