BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDEASY

    MDR report key: 12016283 · Received June 17, 2021

    Report

    Report Number
    12016283
    Event Type
    Malfunction
    Date Received
    June 17, 2021
    Date of Event
    June 11, 2021
    Report Date
    June 14, 2021
    Manufacturer
    MEDAX SRL UNIPERSONALE
    Product Code
    KNW
    UDI-DI
    08054301667419
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WITH HISTORY OF STAGE IV FOLLICULAR LYMPHOMA WAS ADMITTED FOR AN ULTRASOUND BIOPSY OF LYMPH NODE. WHILE PHYSICIAN WAS DOING THE PROCEDURE, THE MEDAX SRL UNIPERSONALE MEDEASY SOFT TISSUE SEMI-AUTOMATIC BIOPSY NEEDLE CAME UNGLUED. ANOTHER BIOPSY NEEDLE WAS USED AND IT CAME UNGLUED AS WELL. BOTH BIOPSY NEEDLES HAD THE SAME LOT #. A THIRD BIOPSY NEEDLE WAS USED WITHOUT PROBLEMS. NO KNOWN HARM DONE TO PATIENT. THIS IS THE 6TH REPORT OF THIS BIOPSY NEEDLE COMING UNGLUED. PURCHASING DEPARTMENT IS AWARE AND HAS ALL LOT NUMBERS: 21-121, 21-75, 21-67, 21-64

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914094 MEDEASY INSTRUMENT, BIOPSY KNW MEDAX SRL UNIPERSONALE ML18080-K0 0618620 08054301667419

    Patients

    Seq Age Sex Outcome Treatment
    1 23725 DA