BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEANASCOPE LINERS

    MDR report key: 15780843 · Received November 11, 2022

    Report

    Report Number
    3012708860-2022-00001
    Event Type
    Malfunction
    Date Received
    November 11, 2022
    Date of Event
    October 13, 2022
    Report Date
    November 11, 2022
    Manufacturer
    CANTEL ITALY S.R.L.
    Product Code
    FFY
    UDI-DI
    18011517135801
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A STERIS SALES REPRESENTATIVES DISCUSSED THE REPORTED EVENT WITH USER FACILITY PERSONNEL WHO STATED THAT SEVERAL CLEANASCOPE LINERS FROM THE LOT SUBJECT OF THE REPORTED EVENT WERE TEARING ALONG THE CENTRAL FOLD PRIOR TO INSTALLMENT IN THE BOTTOM OF THE TRAY. THE REMAINING CLEANASCOPE LINERS FROM THE LOT ASSOCIATED WITH THIS COMPLAINT AT THE USER FACILITY WERE DISPOSED OF. AS THE CLEANASCOPE LINERS WERE DISPOSED OF, STERIS IS UNABLE TO INSPECT AND EVALUATE THE LINERS SUBJECT OF THE REPORTED EVENT; A ROOT CAUSE CANNOT BE DETERMINED. THE USER FACILITY RECEIVED REPLACEMENT PRODUCT AND NO ADDITIONAL ISSUES HAVE BEEN REPORTED. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE WHITE LINER TEARS, ALONG THE CENTRAL FOLD, WHEN IT IS UNFOLDED PRIOR TO BEING INSTALLED IN THE BOTTOM OF THE TRAY. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1199855 CLEANASCOPE LINERS LINERS FFY CANTEL ITALY S.R.L. Sterile Tray Liner System 2106032808 18011517135801

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown