BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEAM STER LOCKS ORANGE

    MDR report key: 14053537 · Received April 8, 2022

    Report

    Report Number
    2916714-2022-00039
    Event Type
    Malfunction
    Date Received
    April 8, 2022
    Date of Event
    March 10, 2022
    Report Date
    May 19, 2023
    Manufacturer
    AESCULAP INC.
    Product Code
    JOJ
    UDI-DI
    05055049091927
    PMA / PMN Number
    K890759
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    MANUFACTURER EVALUATION: THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. A VISUAL EXAMINATION OF THE CHEMICAL INDICATOR REVEALED THAT ONE (1) OF THE INDICATOR DOTS WAS GREY/BLUE AND ONE (1) WAS LIGHT BLUE. BOTH DOTS WERE NOT CONSISTENT WITH THE EXPECTED INITIAL OR FINAL TRANSITION COLOR. THE DEVICE HISTORY RECORDS (DHR) WERE NOT ABLE TO BE REVIEWED AS NO LOT # WAS MADE AVAILABLE. HOWEVER, 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 ABLE TO CONFIRM THE FAILURE MODE OF CHEMICAL INDICATOR FAILED TO TRANSITION TO ITS POST STERILIZATION COLOR.

    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 TRANSITIONED TO ITS POST STERILIZATION COLOR, HOWEVER, THE INDICATOR DOT TURNED BACK TO BLUE AFTER APPROXIMATELY THRITY (30) TO SIXTY (60) DAYS WHILE IN STORAGE IN THE STERILE PROCESSING DEPARTMENT (SPD). THE LOCK WAS NOT IN EXTREME TEMPERATURES WHILE IN STERILE STORAGE WITHIN THE DEPARTMENT. THE CONTAINERS ARE STORED ON NORMAL SHELVING AND ARE NOT EXPOSED TO INTENSE LIGHT. 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
    1110857 STEAM STER LOCKS ORANGE INDICATOR, PHYSICAL/CHEMICAL STERILIZATION PROCESS JOJ AESCULAP INC. US906 05055049091927

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown