BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUNMED

    MDR report key: 9284065 · Received November 6, 2019

    Report

    Report Number
    3006389770-2019-00001
    Event Type
    Malfunction
    Date Received
    November 6, 2019
    Date of Event
    September 10, 2019
    Report Date
    October 15, 2019
    Manufacturer
    MEDITEC DEVICES
    Product Code
    BSR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE REFERENCE SAMPLES OF THE LOT MD163 WERE CHECKED AND NONE OF THE PIECES BROKE OFF OR EXHIBITED THIS TENDENCY. THE TENSILE STRENGTH, THE PARAMETER RELATED TO THIS PROBLEM WAS CHECKED ON ONE PIECE FROM THE REFERENCE SAMPLES AND WAS FOUND TO BE COMPLIANT. WILL BE ABLE TO INVESTIGATE ON RECEIPT OF THIS PARTICULAR PIECE. THE PIECE IS AWAITED.

    Description of Event or Problem · 1

    THE CUSTOMER SAYS THE TIP BROKE OFF THE PRODUCT. NO OTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1077519 SUNMED ET INTRODUCER 9-0212-70 BSR MEDITEC DEVICES 9-0212-70 MD 163

    Patients

    Seq Age Sex Outcome Treatment
    1