BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Q2 EXTENSION SET WITH Y-SITE, 17 INCH

    MDR report key: 3130092 · Received May 21, 2013

    Report

    Report Number
    1649914-2013-00029
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 25, 2013
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    FPK
    PMA / PMN Number
    K800825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE: (B)(4). DEVICE EVALUATION: ALTHOUGH THE ACTUAL DEVICE HAS NOT BEEN RETURNED FOR EVALUATION, QUEST MEDICAL, INC. HAS ALREADY INITIATED AN INVESTIGATION ON THIS ALLEGED ISSUE AND THIS EVENT IS ADDED TO THAT INVESTIGATION. THE INVESTIGATION IS STILL UNDERWAY. 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'S 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 NOTIFIED THE MANUFACTURER THAT THE NURSING UNIT ENCOUNTERED AN ISSUE WITH AN INTRAVASCULAR ADMINISTRATION SET INCLUDING THE Q2 EXTENSION SET MANIFOLD. IT WAS ONLY REPORTED THAT THE SET HAD A LEAK AT THE MANIFOLD FILTER. THE INFUSATE WAS NOT IDENTIFIED; HOWEVER, NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE ALLEGED EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE SET WAS DISCARDED BY THE HOSPITAL AND NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225630 Q2 EXTENSION SET WITH Y-SITE, 17 INCH INTRAVASCULAR ADMINISTRATION SET FPK QUEST MEDICAL, INC. 95902

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention