BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISITEC

    MDR report key: 13081968 · Received December 23, 2021

    Report

    Report Number
    1211998-2021-00075
    Event Type
    Malfunction
    Date Received
    December 23, 2021
    Report Date
    December 23, 2021
    Manufacturer
    BEAVER-VISITEC INTERNATIONAL, INC.
    Product Code
    HMX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS THE RESULT OF A RETROSPECTIVE REVIEW OF PREVIOUSLY UNREPORTED COMPLAINTS FROM OCTOBER 2017-JANUARY 2020.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THAT PRIOR TO THE SURGEON USING THE RYCROFT CANNULA IN A PROCEDURE THAT THE NEEDLE OF THE RYCROFT CANNULA SEPARATED FROM ITS PLASTIC BASE IN THE SURGEON'S HAND. THERE WERE NO REPORTS OF PATIENT OR USER INJURY FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1974996 VISITEC BVI, ANTERIOR CAMBER CANNULA BX/10 STERILE .30MM HMX BEAVER-VISITEC INTERNATIONAL, INC. 6013895

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown