BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYCLESURE BIOLOGICAL INDICATOR

    MDR report key: 1060773 · Received June 12, 2008

    Report

    Report Number
    2084725-2008-00278
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    May 21, 2008
    Report Date
    May 22, 2008
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    FRC
    PMA / PMN Number
    K994055
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TWO CYCLESURE BIOLOGICAL INDICATORS WERE PROCESSED IN THE STERRAD 100S. AFTER 24 HOURS OF INCUBATION, ONE B.I. WAS POSITIVE AND THE OTHER NEGATIVE. THE CUSTOMER DID NOT RECALL ALL ITEMS FROM THE LOAD. THE CUSTOMER STATED THAT THERE WERE NO INJURIES REPORTED RELATED TO THE UNRECALLED ITEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYCLESURE BIOLOGICAL INDICATOR INDICATOR, BIOLOGICAL FRC ADVANCED STERILIZATION PRODUCTS NA 35371Z

    Patients

    Seq Age Sex Outcome Treatment
    1 NA