BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISITEC CANNULA ANTERIOR CHAMBER 30 GAGE (10 PER PACK)

    MDR report key: 5332219 · Received December 29, 2015

    Report

    Report Number
    1211998-2015-00002
    Event Type
    Injury
    Date Received
    December 29, 2015
    Date of Event
    September 30, 2015
    Report Date
    December 2, 2015
    Manufacturer
    BEAVER VISITEC WALTHAM MASS
    Product Code
    HMX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS OR SIMILAR ISSUES HAVE BEEN REPORTED TO BVI IN THE PAST AND IN ALL CASES IT HAS BEEN DETERMINED THROUGH EXHAUSTIVE TESTING AND INVESTIGATION OF PRODUCT THAT THE CANNULA CAN ONLY DETACH FROM THE LUER-LOK SYSTEM AS A PROJECTILE OR OTHERWISE IF THE USER FAILS TO FULLY ENGAGE THE LUER-LOK SUCH THAT THE CONNECTION IS NOT MADE PROPERLY ALLOWING THE CANNULA TO DISENGAGE DURING USE. IN THIS CASE, THE USER WAS NOT ABLE TO PROVIDE THE SPECIFIC DEVICE USED TO BVI FOR FULL EVALUATION AND NO SPECIFIC ISSUES WERE REPORTED. THUS WE ARE UNABLE TO DETERMINE IF ANY PRODUCT ISSUES MAY HAVE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    ( VERBATIM FROM REPORT): "- RECEIVED A FAX FROM THE ANSM ON BEHALF OF THE CUSTOMER STATING A QUALITY PROBLEM WITH THE CANNULAS (B)(4). THE CANNULA DISCONNECTED ITSELF FROM THE LUER-LOCK SYRINGE THUS BEING PROJECTED INTO THE PATIENT 'S EYE. CLINICAL CONSEQUENCES ARE AS FOLLOWS: A CAPSULA RUPTURE , VITREOUS LOSS , DISLOCATION OF THE IMPLANT, SIGNIFICANT INTRAVITREAL HEMORRHAGING." THE PRODUCT IN THIS IS NOT BEING RETURNED FOR INVESTIGATION BY THE END USER WHO STATED IT IS NOT AVAILABLE. THEREFORE, BEAVER VISITEC IS UNABLE TO DETERMINE IF ANY ISSUES SPECIFIC TO THE DEVICE IS IN QUESTION THAT CONTRIBUTED TO THE INCIDENT. HOWEVER, WE HAVE HAD REPORTS OF SIMILAR INCIDENTS AND THROUGH MULTIPLE EXHAUSTIVE INVESTIGATIONS HAVE FOUND THAT THESE ISSUES TO DATE WERE THE RESULT OF USER ERROR AND WERE NOT ATTRIBUTED TO ANY PRODUCT DEFECTS OR DEFICIENCIES. PLEASE REFER TO ATTACHED INVESTIGATION REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855508 VISITEC CANNULA ANTERIOR CHAMBER 30 GAGE (10 PER PACK) CANNULA HMX BEAVER VISITEC WALTHAM MASS 3128499

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention