BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIBLE CYCLE PCD

    MDR report key: 11272059 · Received February 3, 2021

    Report

    Report Number
    3011026564-2020-00001
    Event Type
    Malfunction
    Date Received
    February 3, 2021
    Date of Event
    December 15, 2020
    Report Date
    December 23, 2020
    Manufacturer
    STERILUCENT, INC.
    Product Code
    FRC
    PMA / PMN Number
    K192001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTING FACILITY: (B)(6). NUMBER OF DECONTAMINATION CYCLES AT THE TIME OF THE EVENT: VARIABLE (10 MASK LOAD), NO GREATER THAN 4 DECONTAMINATION METHOD/PROCESS: STERILUCENT HC 80TT HYDROGEN PEROXIDE STERILIZER FLEXIBLE CYCLE BRAND/MODEL OF DECONTAMINATED PRODUCT: 3M 8210, 8201+ EVENT DESCRIPTION: FAILURE OF BIOLOGICAL INDICATOR EVALUATION/INVESTIGATION OF THE REPORTED EVENT: EVALUATION OF PARAMETRIC CYCLE DATA INDICATED ALL PARAMETERS WHERE WITHIN NORMAL ACCEPTABLE RANGES. INVESTIGATION OF THE BI DETERMINED LOT EXHIBITS TAILING. DISPOSITION OF THE LOAD: DISPOSITIONED AS A FAILED CYCLE; CYCLE COUNT INCREMENTED FOR EACH RESPIRATOR; RESPIRATORS WERE REPACKAGED AND REPROCESSED. AFFECTED FACILITIES: (B)(6).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED A POSITIVE BI. THIS REPORT IS REQUIRED UNDER THE TERMS OF THE EUA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167935 FLEXIBLE CYCLE PCD BIOLOGICAL INDICATOR FRC STERILUCENT, INC. PCD-F B200727A5

    Patients

    Seq Age Sex Outcome Treatment
    1