BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BVI CANNULA

    MDR report key: 19510898 · Received June 10, 2024

    Report

    Report Number
    MW5156099
    Event Type
    Malfunction
    Date Received
    June 10, 2024
    Date of Event
    March 18, 2024
    Report Date
    June 6, 2024
    Manufacturer
    BEAVER-VISITEC INTERNATIONAL, INC.
    Product Code
    HMX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BVI CANNULA DISLODGED DURING CATARACT SURGERY AND THE BVI 30G CANNULA FORCIBLY EJECTED INTO THE EYE. THE LENS IMPLANT REMAINED IN POSITION. SAFETY CHECKS WERE PERFORMED PRIOR TO PASSING OFF THE SYRINGE TO THE SURGEON. FORTUNATELY, NO FURTHER PROCEDURE WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189519 BVI CANNULA CANNULA, OPHTHALMIC HMX BEAVER-VISITEC INTERNATIONAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown