BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUER LOCK SET, SINGLE LUMEN

    MDR report key: 9340862 · Received November 19, 2019

    Report

    Report Number
    9340862
    Event Type
    Malfunction
    Date Received
    November 19, 2019
    Date of Event
    September 18, 2019
    Report Date
    October 28, 2019
    Manufacturer
    THERMEDX, LLC
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE INNER ASPECT OF MALE ADAPTOR OF THE TUBING THAT SCREWS INTO THE SHEATH FOR THE HYSTEROSCOPE BROKE OFF INTO THE FEMALE CONNECTION POINT. THE INNER ASPECT OF THE MALE ADAPTER OF THE TUBING THAT SCREWS INTO THE SHEATH FOR THE HYSTEROSCOPE BROKE OFF INTO THE FEMALE CONNECTION POINT. THE HYSTEROSCOPE WAS NOT IN THE PATIENT AT THE TIME OF BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1135989 LUER LOCK SET, SINGLE LUMEN ARTHROSCOPE HRX THERMEDX, LLC LL0002 19A25N

    Patients

    Seq Age Sex Outcome Treatment
    1 22995 DA