BEUDAMED
    FDA Adverse Event Other Summary report: N

    VISITEC ANTERIOR CHAMBER CANNULA

    MDR report key: 2956433 · Received February 4, 2013

    Report

    Report Number
    1211998-2013-00001
    Event Type
    Other
    Date Received
    February 4, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 31, 2013
    Manufacturer
    BEAVER VISITEC INTERNATIONAL, INC.
    Product Code
    HMX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A (B)(4) UNITS WERE PRODUCED IN THIS CANNULA LOT. A TOTAL OF (B)(4) UNITS HAVE BEEN MANUFACTURED SINCE (B)(4). THERE WAS TOTAL OF (B)(4) ISSUES INCLUDING THESE TWO COMPLAINTS. THE TEST RESULTS ABOVE INDICATED THERE WAS NO FAILURE AND/OR COULDN'T REPEAT THE ACTUAL FAILURE STATED IN THE COMPLAINT THAT "THE CANNULA FLEW OFF THE SYRINGE". WHEN THE CANNULA AND SYRINGE ARE PROPERLY INSTALLED AND PRODUCT IS USED PROPERLY, THIS FAILURE SHALL NOT OCCUR BASED ON THE INTENDED USE OF THE PRODUCT. WE HAVE COMMUNICATED TO THE (B)(4) ASSOCIATES THIS COMPLAINT IN ORDER TO HEIGHTEN OPERATOR AWARENESS. NO FURTHER CORRECTIVE ACTION IS REQUIRED AT THIS TIME. WE WILL CONTINUE TO MONITOR FOR FUTURE INCIDENTS OF THIS NATURE. FURTHER CORRECTIVE ACTION WILL BE TAKEN IF PRODUCTION ASSOCIATES FIND NONCONFORMITIES RELATED TO THIS ISSUE OR COMPLAINTS OF THIS NATURE INCREASE.

    Description of Event or Problem · 1

    FINAL REPORT. BVI BECAME AWARE ON (B)(4) 2013 THAT AN INCIDENT OCCURRED ON (B)(6) 2013. SUMMARY OF COMPLAINTS: BVI RECEIVED 2 COMPLAINTS FROM THE SAME SITE LISTED BELOW. THE SAME PRODUCT, CATALOG NUMBER 581273, ANTERIOR CHAMBER CANNULA, WAS USED FOR THE SAME TECHNIQUE OF STROMAL HYDRATION DURING CATARACT SURGERY, WHEN THE CANNULA DISCONNECTED FROM THE SYRINGE (BECTON DICKINSON, BD CATALOG NUMBER 305906). BOTH SURGEONS WERE CONTACTED BY BVI. BOTH PATIENTS WILL BE FINE PER THE SURGEONS, HOWEVER BOTH PATIENTS WERE SENT TO A RETINAL SPECIALIST. BOTH PATIENTS HAD VITREOUS HEMORRHAGES, BUT ONLY ONE NEEDED A SECOND SURGERY (VITRECTOMY WITH A SULCUS-PLACE IOL). BVI CONDUCTED AN INVESTIGATION WHICH INCLUDED TESTING THAT REVEALED THAT PRODUCT FROM THE SAME LOT AND RETURNED PRODUCT FROM THE CUSTOMER, ALSO THE SAME LOT (BOTH CANNULA AND SYRINGE), FUNCTIONS AS INTENDED WITH NO DISCONNECTION OF THE CANNULA FROM THE SYRINGE. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45877 VISITEC ANTERIOR CHAMBER CANNULA CANNULA HMX BEAVER VISITEC INTERNATIONAL, INC. NA 3027553

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention