BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEAVER-VISITEC INTERNATIONAL INC

    MDR report key: 19548761 · Received June 17, 2024

    Report

    Report Number
    1211998-2024-00012
    Event Type
    Malfunction
    Date Received
    June 17, 2024
    Date of Event
    January 26, 2024
    Report Date
    June 17, 2024
    Manufacturer
    BEAVER-VISITEC INTERNATIONAL INC
    Product Code
    HMX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BVI QUALITY ASSURANCE HAS FOLLOWED ITS INTERNAL PROCEDURE TO CONDUCT THE APPROPRIATE COMPLAINT INVESTIGATION. THE INVESTIGATION INCLUDES A REVIEW OF THE PROCEDURE / TRAINING RECORD, AND NO ANOMALIES WERE FOUND. AS PART OF THE INVESTIGATION, IT WAS FOUND THAT THE DEVICE WAS PRODUCED IN JANUARY 2023, DURING THE MANUAL BRUSHING PROCESS (BIDFORD SITE OLD SITE OF MANUFACTURING), NOWADAYS THIS COMPONENT IS MANUFACTURED IN JUAREZ SITE AND A NEW MANUFACTURING PROCESS WAS ADDED, ROLLER PROCESS INSTEAD OF MANUAL BRUSHING PROCESS. ADDED ON PROCEDURE D179MX, REV. 02, RELEASED ON 11/30/2023. COMPLAINT DATABASE WAS REVIEWED, THIS IS CONSIDERED A SINGLE AND AN ISOLATED CASE. COMPLAINT DATABASE WAS REVIEWED, AND NO ADDITIONAL ACTIONS ARE REQUIRED AT THIS POINT. BVI WILL CONTINUE TO MONITOR ANY FEEDBACK FROM OUR CUSTOMER AND TAKE APPROPRIATE ACTION IF AN UNFAVOURABLE TREND IS OBSERVED.

    Description of Event or Problem · 0

    CUSTOMER ALLEGED " SMALL METAL BARB OBSERVED ON CANNULA WHICH CAUSED HARM TO PATIENT".

    Description of Event or Problem · 0

    CUSTOMER ALLEGED " SMALL METAL BARB OBSERVED ON CANNULA WHICH CAUSED HARM TO PATIENT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2323755 BEAVER-VISITEC INTERNATIONAL INC VISITEC® I AND A CANNULA, [SIMCOE] HMX BEAVER-VISITEC INTERNATIONAL INC 585047 3461112

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other