BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEAVER-VISITEC INTERNATIONAL INC

    MDR report key: 19235004 · Received May 2, 2024

    Report

    Report Number
    1211998-2024-00010
    Event Type
    Malfunction
    Date Received
    May 2, 2024
    Date of Event
    August 4, 2024
    Report Date
    May 2, 2024
    Manufacturer
    BEAVER-VISITEC INTERNATIONAL INC
    Product Code
    HNN
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, CA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CLARION HAS REPORTED THIS EVENT TO THE MANUFACTURER BVI. MEANWHILE CLARION IS ACTIVELY FOLLOWING UP WITH THE COMPLAINANT TO RECEIVE ANY UPDATES OR INFORMATION RELATED TO THIS EVENT. ADDITIONAL INFORMATION WILL BE PROVIDED UPON THE INVESTIGATION COMPLETION BY BVI.

    Additional Manufacturer Narrative · 0

    CLARION HAS REPORTED THIS EVENT TO THE MANUFACTURER BVI. MEANWHILE CLARION IS ACTIVELY FOLLOWING UP WITH THE COMPLAINANT TO RECEIVE ANY UPDATES OR INFORMATION RELATED TO THIS EVENT. ADDITIONAL INFORMATION WILL BE PROVIDED UPON THE INVESTIGATION COMPLETION BY BVI. NO SAMPLE WAS AVAILABLE OR PICTURES. THE LOT INVOLVED COULD NOT BE REVIEWED BECAUSE THE INFORMATION OF LOT NUMBER WAS NOT AVAILABLE. HOWEVER, ANOTHER LOT NUMBER 6067986 WITH THE SAME PART NUMBER 378227 - SLIT KNIFE 2.75MM ANGL SNGL BEV W/SAFETY (10/SP) WAS CHECKED AND NO SAFETY CAPS WERE FOUND IN THE OPEN POSITION. THE COMPLAINT WAS ACKNOWLEDGED BY CUSTOMER INFORMATION AND ADDED TO BVI RECORDS.

    Description of Event or Problem · 0

    ON APRIL 10 2024, CLARION WAS INFORMED BY THE CUSTOMER THAT FEW NURSES GOT INJURED WITH THE CUTS ON THEIR FINGERS WHILE OPENING THE PACKAGE OF THE SAFETY KNIFE. SEVERAL KNIVES WERE NOTED TO HAVE THEIR SAFETY CAPS IN THE OPEN POSITION WITHIN THE PACKAGING, WHICH RESULTING IN A FEW CUTS TO NURSES FINGERS. INCIDENT HAPPENED IN CANADA AND WAS REPORTED TO HEALTH CANADA UNDER REPORT #(B)(4) ON 4/28/2024.

    Description of Event or Problem · 0

    ON APRIL 10 2024, CLARION WAS INFORMED BY THE CUSTOMER THAT FEW NURSES GOT INJURED WITH THE CUTS ON THEIR FINGERS WHILE OPENING THE PACKAGE OF THE SAFETY KNIFE. SEVERAL KNIVES WERE NOTED TO HAVE THEIR SAFETY CAPS IN THE OPEN POSITION WITHIN THE PACKAGING, WHICH RESULTING IN A FEW CUTS TO NURSES FINGERS. INCIDENT HAPPENED IN CANADA AND WAS REPORTED TO HEALTH CANADA UNDER REPORT # (B)(4) ON 4/228/2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847093 BEAVER-VISITEC INTERNATIONAL INC BVI SLIT KNIFE 2.75MM ANGL SNGL BEV W/SAFETY (10/BX) HNN BEAVER-VISITEC INTERNATIONAL INC 378227 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other