BEUDAMED
    FDA Adverse Event Other Summary report: N

    BEAVER MINI-BLADES

    MDR report key: 2787970 · Received October 5, 2012

    Report

    Report Number
    MW5027204
    Event Type
    Other
    Date Received
    October 5, 2012
    Report Date
    October 5, 2012
    Manufacturer
    BEAVER-VISITEC INTERNATIONAL, INC.
    Product Code
    GES
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    BEAVER MINI-BLADES ((B)(4)). THE BEAVER MINI BLADE IS NOW COMING PACKAGED IN A WHITE ¿SAFETY¿ TRAY. NURSE RECEIVED A MINOR LACERATION WHICH WAS REPAIRED WITH DERMABOND IN EMPLOYEE HEALTH. NURSE RETURNED TO WORK WITHIN HOUR. THE POINT IS THAT IT IS A NEW DEVICE AND EDUCATION DID NOT GO OUT INSTRUCTING USERS HOW TO REMOVE THE BLADE FROM PACKAGING. INSTRUCTIONS WERE FOUND ON THE WEBSITE. PLEASE REFER TO THE INSTRUCTION SHEET FROM THEIR WEBSITE WHICH IS HOW THE NURSE DID OPEN IT. UNABLE TO ATTACH IT. PLEASE REFER TO THE OPERATING ROOM NURSE MANAGER RECOMMENDATIONS TO DESIGN ENGINEER. THE OPERATING ROOM NURSE CONTACTED THE DESIGN ENGINEER WHO MADE THE TRAY AND RECOMMENDED THE LITERATURE SHOW THE HAND UNDER THE WHITE TRAY RATHER THAN PARALLEL TO THE TOP OT THE TRAY. THE SHOWN PROCESS OF HOLDING THE TRAY CAN LEAD TO A PUNCTURE IN THE HAND SHOULD THE BLADE SLIP FORWARD IN THE TRAY AS YOU ASSEMBLE THE HANDLE. PLEASE HOLD IT WITH THUMB AND FIRST FINGER WITH YOUR HAND UNDER THE TRAY. THE PERSON SHE TALKED TO WAS (B)(4). HE SAYS HE WAS THE DESIGN ENGINEER. HE IS GOING TO TAKE THE RECOMMENDATIONS BACK TO MARKETING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BEAVER MINI-BLADES MINI-BLADES GES BEAVER-VISITEC INTERNATIONAL, INC. 6900

    Patients

    Seq Age Sex Outcome Treatment
    1