BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEAVER-VISITEC INTERNATIONAL INC

    MDR report key: 19784744 · Received July 19, 2024

    Report

    Report Number
    1211998-2024-00014
    Event Type
    Malfunction
    Date Received
    July 19, 2024
    Date of Event
    July 9, 2024
    Report Date
    October 21, 2024
    Manufacturer
    BEAVER-VISITEC INTERNATIONAL INC
    Product Code
    HNN
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 CURRENT PROCESS AND DEVICE HISTORY RECORD (DHR). ALL REQUIRED ELEMENTS OF THE DHR WERE PROPERLY FILLED. ALL MANUFACTURING OPERATIONS WERE RECORDED; ALL SIGNATURES AND DATES WERE PRESENT, AND THE LOT PASSED THE REQUIRED INSPECTIONS. THE CUSTOMER PROVIDED PICTURES OF THE DEFECTIVE PRODUCT FOR FURTHER INVESTIGATION. UPON REVIEWE, THE REPORTED DEFECT "SHIELD RETRACTED" ON THE KNIFE'S PACKAGING WAS CLEARLY VISIBLE AND CONFIRMED. ACCORDING TO THE INVESTIGATION, THE DEFECT MAY APPEAR DURING TRANSPORTATION CAUSING THE SHIELD TO RETRACT. WHICH IS NOT ACCEPTABLE ACCORDING TO PRODUCT SPECIFICATIONS. BVI WILL CONTINUE TO MONITOR ANY FEEDBACK FROM OUR CUSTOMERS AND TAKE APPROPRIATE ACTION IF AN UNFAVOURABLE TREND IS OBSERVED.

    Description of Event or Problem · 0

    BVI HAS BEEN NOTIFIED ABOUT KNIFES THAT WERE PACKED WITHOUT THE PROTECTION ON THE BLADE AND THERE IS ONE INCIDENT OF A NURSE "STABBING" HERSELF WHILE HANDLING THE KNIFE STILL PACKED IN THE WHITE CONTAINER. THE INCIDENT OCCURRED IN NETHERLANDS.

    Description of Event or Problem · 0

    THE HOSPITAL PROVIDED ADDITIONAL INFORMATION REGARDING THE NURSE OUTCOME. AS IT WAS STATED, THE NURSING STAFF DID NOT REPORT MISSED WORKING HOURS AND THERE WAS NO INTERNAL REPORT OF A NEEDLESTICK INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1552368 BEAVER-VISITEC INTERNATIONAL INC BEAVER® SAFETY SIDEPORT KNIFE 1.15MM 45° HNN BEAVER-VISITEC INTERNATIONAL INC 378231 6066482

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other