BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUKE DECONTAMINATION SYSTEM, EUA 200335

    MDR report key: 10754504 · Received October 29, 2020

    Report

    Report Number
    3017487795-2020-00001
    Event Type
    Malfunction
    Date Received
    October 29, 2020
    Date of Event
    August 17, 2020
    Report Date
    October 27, 2020
    Manufacturer
    DUKE UNIVERSITY HEALTH SYSTEM
    Product Code
    QKY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    RECEIVED THE FOLLOWING A-016 REPORT THROUGH EMAIL: "AT 1310 I WAS DRAWING LABS ON MY COVID POSITIVE PATIENT. IN THE MIDDLE OF THE LAB DRAW, ONE OF THE N95 MASK STRAPS BROKE AND UNSEALED AROUND MY FACE LEAVING ME EXPOSED. MEDICAL FOLLOW-UP AT (B)(6) NOT PLANNED. BREAK IN PPE FOR 3 MINUTES WHILE WORKING WITH COVID+ PATIENT. ADVISED TO CONTACT COVID HOTLINE IF SYMPTOMS DEVELOP". MASK WAS DISCARDED BY EMPLOYEE AND SUBSEQUENT FOLLOW-UP COULD NOT DETERMINE IF THE MASK WAS NEW OR FROM THE DUKE DECONTAMINATION PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1224612 DUKE DECONTAMINATION SYSTEM, EUA 200335 N95 RESPIRATOR DECONTAMINATION SYSTEM QKY DUKE UNIVERSITY HEALTH SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR