BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEXIUM CLOSED MALE LUER

    MDR report key: 8913247 · Received August 20, 2019

    Report

    Report Number
    9616066-2019-02375
    Event Type
    Malfunction
    Date Received
    August 20, 2019
    Date of Event
    July 20, 2019
    Report Date
    July 22, 2019
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    UDI-DI
    10885403221705
    PMA / PMN Number
    K053049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: FLUSH SYRINGE, PORT; CAD NFV. ALTHOUGH REQUESTED, THE AFFECTED PRODUCT HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE PRODUCT BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE USER NOTICED ON THE TEXIUM CLOSED MALE LUER WITH FEMALE CAP HAD A VALVE ISSUE ( PISTON SLANTED) AND MADE IT DIFFICULT TO REMOVE. THE RN HAD TO CAP THE NEEDLE PORT LINE REMOVE THE NEEDLESS CONNECTOR AND THEN ADD THE FLUSH SYRINGE TO PROVIDE A POST THERAPY FLUSH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702984 TEXIUM CLOSED MALE LUER SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 10012241-0500 19026458 10885403221705

    Patients

    Seq Age Sex Outcome Treatment
    1