BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BATTELLE CCDS CRITICAL CARE DECONTAMINATION SYSTEM

    MDR report key: 11267196 · Received February 2, 2021

    Report

    Report Number
    1523658-2021-00047
    Event Type
    Injury
    Date Received
    February 2, 2021
    Date of Event
    January 17, 2021
    Report Date
    January 29, 2021
    Manufacturer
    BATTELLE MEMORIAL INSTITUTE
    Product Code
    QKY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BATTELLE CRITICAL CARE DECONTAMINATION SYSTEM CCDS TM SITE WORKER HAD A POSITIVE DIAGNOSTIC TEST RESULT FOR SARS-COV-2. THE BATTELLE CCDS SITE WORKER WORE PERSONAL PROTECTIVE EQUIPMENT (PPE) LEVEL 4 FULLY ENCAPSULATED PROTECTIVE SUIT WITH POSITIVE PRESSURE AND SELF-CONTAINED BREATHING APPARATUS WHILE HANDLING CONTAMINATED N95 RESPIRATORS. THEREFORE, THE CCDS SITE WORKER'S INFECTION IS NOT BEING ATTRIBUTED TO THE BATTELLE CRITICAL CARE DECONTAMINATION SYSTEM CCDS. THE CCDS IS USED IN THE DECONTAMINATION OF COMPATIBLE N95 RESPIRATORS TO PREVENT EXPOSURE TO PATHOGENIC BIOLOGICAL AIRBORNE PARTICULATES. BECAUSE THE BATTELLE CCDS SITE WORKER IS REQUIRED, PURSUANT TO BATTELLE'S STANDARD OPERATING PROCEDURES, TO WEAR PPE LEVEL 4 FULLY ENCAPSULED PROTECTIVE SUIT WITH POSITIVE PRESSURE AND SELF-CONTAINED BREATHING APPARATUS WHILE HANDLING CONTAMINATED N95 RESPIRATORS, THE SITE WORKER WAS NOT WEARING A N95 RESPIRATOR THAT HAD BEEN REPROCESSED UNDER THE FDA'S EMERGENCY USE AUTHORIZATION (EUA) APPROVED MARCH 29, 2020, AND REVISED AND REISSUED ON JUNE 6, 2020.

    Description of Event or Problem · 1

    A BATTELLE CRITICAL CARE DECONTAMINATION SYSTEM CCDS SITE WORKER HAD A POSITIVE DIAGNOSTIC TEST RESULT FOR SARS-COV-2. THE BATTELLE CCDS SITE WORKER WORE PERSONAL PROTECTIVE EQUIPMENT (PPE) LEVEL 4 FULLY ENCAPSULATED PROTECTIVE SUIT WITH POSITIVE PRESSURE AND SELF-CONTAINED BREATHING APPARATUS WHILE HANDLING CONTAMINATED N95 RESPIRATORS. THEREFORE, THE CCDS SITE WORKER'S INFECTION IS NOT BEING ATTRIBUTED TO THE BATTELLE CRITICAL CARE DECONTAMINATION SYSTEM CCDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165200 BATTELLE CCDS CRITICAL CARE DECONTAMINATION SYSTEM DECONTAMINATION SYSTEMS FOR N95 RESPIRATORS QKY BATTELLE MEMORIAL INSTITUTE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other