BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDEASY

    MDR report key: 11964806 · Received June 9, 2021

    Report

    Report Number
    11964806
    Event Type
    Malfunction
    Date Received
    June 9, 2021
    Date of Event
    May 27, 2021
    Report Date
    May 27, 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 CHRONIC OBSTRUCTIVE PULMONARY DISEASE AND INCREASING SHORTNESS OF BREATH WAS ADMITTED FOR A SOFT-TISSUE RIGHT BREAST BIOPSY. PRIOR TO INSERTING NEEDLE INTO PATIENT, THE MEDAX SRL UNIPERSONALE MEDEASY SOFT TISSUE SEMI-AUTOMATIC BIOPSY NEEDLE 18G X 80 MM (LOT # 06186-20, REF # ML18080-KO) CAME UNGLUED. THE DEFECTIVE NEEDLE WAS NEVER PLACED INTO THE PATIENT. ANOTHER OF THE SAME TYPE AND LOT # OF THAT NEEDLE WAS OPENED AND USED. THIS IS NOT THE FIRST EVENT FOR THIS PRODUCT, REPORTED SAME INCIDENT WITH THIS TYPE OF DEVICE IN THE RECENT PAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861168 MEDEASY INSTRUMENT, BIOPSY KNW MEDAX SRL UNIPERSONALE ML18080-K0 06186-20 08054301667419

    Patients

    Seq Age Sex Outcome Treatment
    1 23360 DA