BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2 WAY EXTENSION SET - WITH LUER LOCKS

    MDR report key: 7063327 · Received November 28, 2017

    Report

    Report Number
    MW5073575
    Event Type
    Malfunction
    Date Received
    November 28, 2017
    Date of Event
    November 22, 2017
    Report Date
    November 22, 2017
    Manufacturer
    CODAN US CORPORATION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BIFUSE DISCONNECTED FROM CENTRAL LINE. MALE ADAPTOR PIECE BROKE; DISLODGED INTO CLEAR CLAVE. CLAVE REPLACED USING STERILE PROCEDURE. TUBING REPLACED WITHOUT THE USE OF BIFUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841954 2 WAY EXTENSION SET - WITH LUER LOCKS SET, ADMINISTRATION FPA CODAN US CORPORATION BC 554 74030

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR