BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERIM

    MDR report key: 23842724 · Received December 18, 2025

    Report

    Report Number
    3004080920-2025-00002
    Event Type
    Malfunction
    Date Received
    December 18, 2025
    Date of Event
    November 18, 2025
    Report Date
    December 18, 2025
    Manufacturer
    TRUE INDICATING LLC
    Product Code
    FRC
    UDI-DI
    00197644080601
    PMA / PMN Number
    K200970
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD WAS REVIEWED AND CONFIRMED THE LOT SUBJECT OF THE EVENT WAS MANUFACTURED TO SPECIFICATIONS. A COMPLAINT REVIEW WAS PERFORMED AND CONFIRMED THE REPORTED EVENT TO BE ISOLATED. THE REPORTED EVENT MAY BE ATTRIBUTED TO THE CAP FOR THE BIOLOGICAL INDICATOR BEING LOOSE BEFORE IT WAS PLACED IN THE INCUBATOR. THE CAP SHOULD BE TIGHTENED AFTER THE BIOLOGICAL INDICATOR IS ACTIVATED (CRUSHED). THROUGH FOLLOW-UP, IT WAS STATED THAT USER FACILITY PERSONNEL UTILIZED A VIAL CRUSHER TO ACTIVATE THE BIOLOGICAL INDICATOR; HOWEVER, THE VIAL CRUSHER IS NOT A STERIS PRODUCT AND MAY BE INCOMPATIBLE WITH THE SELF-CONTAINED BIOLOGICAL INDICATOR SUBJECT OF THE REPORTED EVENT. STERIS IS THE CONTRACT MANUFACTURER OF THE DEVICE SUBJECT OF THE EVENT AND DOES NOT HAVE THE USER FACILITY CONTACT INFORMATION. STERIS NOTIFIED THE MANUFACTURER, TRUE INDICATING LLC, TO PROVIDE THE INVESTIGATION RESULTS AND PERFORM RETRAINING WITH THE USER FACILITY. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT WHEN AN EMPLOYEE REMOVED THE SELF-CONTAINED BIOLOGICAL INDICATOR FROM THE INCUBATOR, A PIECE OF THE ACTIVATED (CRUSHED) BIOLOGICAL INDICATOR VIAL CONTACTED THEIR FACE RESULTING IN A SCRATCH. NO MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2242804 STERIM BIOLOGICAL INDICATOR FRC TRUE INDICATING LLC SRI-050 (10)S012 00197644080601

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown