BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEAVER-VISITEC INTERNATIONAL INC

    MDR report key: 19724417 · Received July 11, 2024

    Report

    Report Number
    1211998-2024-00013
    Event Type
    Malfunction
    Date Received
    July 11, 2024
    Date of Event
    July 1, 2024
    Report Date
    October 21, 2024
    Manufacturer
    BEAVER-VISITEC INTERNATIONAL INC
    Product Code
    HMX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BVI QUALITY ASSURANCE HAS FOLLOWED ITS INTERNAL PROCEDURE TO CONDUCT THE APPROPRIATE COMPLAINT INVESTIGATION. THE VIDEO AND PICTURE WERE PROVIDED BY CUSTOMER. THE FAILURE MODE AS DESCRIBED WAS NOT CLEAR IN THE VIDEO, THE PICTURE WAS EVALUATED AND THE TIP OF THE CANNULA SHOWS A DIFFERENT CONDITION TO THOSE USUALLY CONSTRUCTED. AS A RESULT OF THE INVESTIGATION THE FAILURE MODE, AS ALLEGED BY THE CUSTOMER, WAS NOT CONFIRMED. ADDITIONALLY, DUE TO NO SAMPLE AVAILABILITY FOR ANALYSIS, BVI IS UNABLE TO ATTRIBUTE THIS TO THE MANUFACTURING PROCESS AS THERE WERE NO DEVIATIONS FOUND DURING MANUFACTURING UPON REVIEW OF THE DEVICE HISTORY RECORD (DHR) DOCUMENTATION. THE EXACT ROOT CAUSE WAS NOT IDENTIFIED. COMPLAINT DATABASE WAS REVIEWED, AND NO FURTHER ACTIONS ARE REQUIRED AT THIS POINT.

    Description of Event or Problem · 0

    CUSTOMER ALLEGED " 27G CANNULAS WERE DEFECTIVE AND PUNCTURED THE ANTERIOR CAPSULE"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2385224 BEAVER-VISITEC INTERNATIONAL INC BULK CANN ANTERIOR CHAMBER .40MM (100/SP) HMX BEAVER-VISITEC INTERNATIONAL INC 585736 6066047

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention