BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER SCT40

    MDR report key: 18397025 · Received December 27, 2023

    Report

    Report Number
    3013145340-2023-00002
    Event Type
    Malfunction
    Date Received
    December 27, 2023
    Date of Event
    October 12, 2023
    Report Date
    December 22, 2023
    Manufacturer
    TERRAGENE S.A.
    Product Code
    JOJ
    UDI-DI
    07798164678205
    PMA / PMN Number
    K191021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SIGNS OF POSSIBLE INSTABILITY OF THE PRODUCT. POSSIBLE COLOR CHANGE INSIDE THE ORIGINAL PACKAGE SINCE WE DO NOT HAVE OBJECTIVE EVIDENCE ABOUT THE TIME THE TAPE WAS EXPOSED TO LIGHT. THE RETAIN SAMPLE DID NOT SHOW COLOR CHANGE. HOWEVER, THERE IS A POSSIBILITY OF THE DEVICE NOT MEETING ITS SPECIFICATIONS, WHICH MAY CAUSE THE DEVICE TO FAIL TO PERFORM ITS ESSENTIAL FUNCTION AND COMPROMISE THE STERILIZATION PROCESS MONITORING EFFECTIVENESS WHICH COULD CONTRIBUTE TO A SERIOUS INJURY.

    Description of Event or Problem · 0

    AN IMPORTER REPRESENTATIVE INFORMED OF OPENED TWO TAPES AND THEY TURNED GREEN IN THE CONFERENCE ROOM OF A HOTEL WITH NO CHEMICAL PRESENCE AND A MINIMAL LIGHT EXPOSURE, AS THEY WERE STORED PRIMARLY IN THEIR PACKAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1570620 STRYKER SCT40 CHEMICAL INDICATOR TAPE JOJ TERRAGENE S.A. STRYKER SCT40 UNKNOWN 07798164678205

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown