BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VARIAN MEDICAL SYSTEMS TRANSFER GUIDE TUBE WITH INTEGRATED QUICK CONNECT FOR AFT

    MDR report key: 15391341 · Received September 8, 2022

    Report

    Report Number
    MW5111948
    Event Type
    Malfunction
    Date Received
    September 8, 2022
    Date of Event
    June 29, 2022
    Report Date
    September 6, 2022
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    JAQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    (B)(6) DISCOVERED A DEVIATION IN THE LENGTH OF THE VARIAN CLICKFIT TRANSFER TUBE CHANNEL USED ON THE VARIAN VARISOURCE HDR AFTERLOADER. USING VARISOURCE MEASUREMENT WIRE AND RULER, ON (B)(6) 2021 THE TUBE MEASURED 119.9CM. ON (B)(6) 2022 THE SAME TUBE MEASURED 122.9 CM. THE LONGER TUBE MAY HAVE LED TO INCORRECT TREATMENT OF PATIENTS THROUGH UNDEREXPOSURE. PATIENTS MAY HAVE RECEIVED RADIATION DOSES DIFFERENT FROM PRESCRIBED DOSES. THERAPY DATES: (B)(6) 2021 - (B)(6) 2022. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2545947 VARIAN MEDICAL SYSTEMS TRANSFER GUIDE TUBE WITH INTEGRATED QUICK CONNECT FOR AFT SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED JAQ VARIAN MEDICAL SYSTEMS, INC. GM19001010 (10)V12

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other