BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3012307300-2020-03233

    MDR report key: 9988194 · Received April 22, 2020

    Report

    Report Number
    3012307300-2020-03233
    Event Type
    Injury
    Date Received
    April 22, 2020
    Date of Event
    January 1, 2020
    Report Date
    April 22, 2020
    Product Code
    BTO
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    (1/2 REFERENCE (B)(4) FOR ALL RELATED COMPLAINTS). SMJ#CFFF107. DURING THE USE OF THE PRODUCT (A TUBE), BRACHIOCEPHALIC ARTERY FISTULA OCCURRED IN THE PATIENT. THE CUSTOMER SUSPECTED THAT SOMETHING WAS WRONG WITH THE LENGTH AND THE ANGLE OF THE PRODUCT. THEREFORE, THEY SWITCHED IT TO COMPETITOR'S ONES. THE AFFECTED ITEM IS EITHER 100/860, 100/811, OR 100/800.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452430 BTO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1