BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEAVER

    MDR report key: 14605826 · Received June 6, 2022

    Report

    Report Number
    1211998-2022-00049
    Event Type
    Malfunction
    Date Received
    June 6, 2022
    Date of Event
    May 10, 2022
    Report Date
    April 6, 2023
    Manufacturer
    BEAVER-VISITEC INTERNATIONAL, INC.
    Product Code
    HNN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). (7 OF 11).

    Additional Manufacturer Narrative · 0

    THE UDI NUMBER WAS UPDATED. 7 OF 11.

    Description of Event or Problem · 0

    A CUSTOMER ALLEGED THAT THE SAFETY SHIELD ON THE SIDEPORT KNIFE 1MM ANGLED W/ SAFETY 10/SP WAS IDENTIFIED AS RETRACTED AND A TECH PRICKED HER FINGER. NO MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645764 BEAVER SIDEPORT KNIFE 1MM ANGLED W/SAFETY HNN BEAVER-VISITEC INTERNATIONAL, INC. 60494441

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown