BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEAM STER LOCKS ORANGE

    MDR report key: 12821687 · Received November 16, 2021

    Report

    Report Number
    2916714-2021-00228
    Event Type
    Malfunction
    Date Received
    November 16, 2021
    Date of Event
    November 5, 2021
    Report Date
    February 24, 2023
    Manufacturer
    AESCULAP INC.
    Product Code
    JOJ
    UDI-DI
    05055049091927
    PMA / PMN Number
    K890759
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER EVALUATION: THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. HOWEVER, A REVIEW OF THE PROVIDED LOT NUMBER REVEALED THAT THE PRODUCT EXPIRED IN JUNE 2019. THE DEVICE HISTORY RECORDS (DHR) WERE REVIEWED FOR ALL AVAILABLE LOT NUMBERS; THE DEVICES WERE FOUND TO BE WITHIN SPECIFICATION AT THE TIME OF PRODUCTION. ALL DEVICE HISTORY RECORDS (DHR) ARE REVIEWED AND RELEASED ACCORDING TO DOCUMENTED PROCEDURES AND A DEVICE IS NOT RELEASED IF IT DOES NOT MEET REQUIREMENTS OR IS NONCONFORMING. THE INVESTIGATION INTO THE CAUSE OF THE REPORTED PROBLEM WAS NOT ABLE TO CONFIRM THE FAILURE MODE OF CHEMICAL INDICATOR FAILED TO TRANSITION TO ITS POST STERILIZATION COLOR. HOWEVER, THE ISSUE LIKELY OCCURRED DUE TO THE DEVICE BEING USED AFTER ITS EXPIRATION DATE.

    Additional Manufacturer Narrative · 0

    MANUFACTURER EVALUATION: INVESTIGATION ON-GOING. SHOULD RELEVANT ADDITIONAL / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO AESCULAP INC. THAT A STEAM STER LOCKS ORANGE (PART # US906) WAS USED TO SECURE A STERILIZATION CONTAINER. ACCORDING TO THE COMPLAINANT, THE INDICATOR DOT FAILED TO TRANSITION TO ITS POST STERILIZATION COLOR. THE COMPLAINT DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1719000 STEAM STER LOCKS ORANGE INDICATOR, PHYSICAL/CHEMICAL STERILIZATION PROCESS JOJ AESCULAP INC. US906 1606 05055049091927

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown