BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BVI VISITEC

    MDR report key: 7654473 · Received June 29, 2018

    Report

    Report Number
    MW5078183
    Event Type
    Injury
    Date Received
    June 29, 2018
    Date of Event
    June 27, 2018
    Report Date
    June 28, 2018
    Manufacturer
    BEAVER-VISITEC INTERNATIONAL
    Product Code
    HMX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    BVI VISITEC ANTERIOR CHAMBER CANNULA (RYCROFT) .30 X 22 MM USED ON LUER LOCK SYRINGE. THIS IS THE 3RD CASE WHERE THE CANNULA "POPS" OFF THE SYRINGE WHILE IN USE. CASE #1 - NO DAMAGE TO EYE. CASE #2 - DAMAGE TO EYE AS THE CANNULA "POPPED" OFF DURING USE WHILE INJECTING IN EYE. CASE #3 - MINOR DAMAGE/BLEEDING DUE TO SAME ISSUE. CANNULA POPPED OFF DURING INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495803 BVI VISITEC ANTERIOR CHAMBER CANNULA HMX BEAVER-VISITEC INTERNATIONAL 585738 3210654
    495804 BVI VISITEC ANTERIOR CHAMBER CANNULA HMX BEAVER-VISITEC INTERNATIONAL 585738
    495805 BVI VISITEC ANTERIOR CHAMBER CANNULA HMX BEAVER-VISITEC INTERNATIONAL 585738

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Other| S