BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYCLESURE BIOLOGICAL INDICATOR

    MDR report key: 1191175 · Received September 26, 2008

    Report

    Report Number
    2084725-2008-00591
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 1, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (OTHER, SUSPECTED POSITIVE BI).

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED THAT THE CUSTOMER HAD A POSITIVE BIOLOGICAL INDICATOR (BI). THE CUSTOMER REPORTED THAT NOT ALL OF THE DEVICES WERE RECALLED. THE AFFILIATE STATED THAT PER THEIR COMMUNICATION WITH THE CUSTOMER, THERE WAS NO INFO PROVIDED REGARDING PT INJURIES. THE AFFILIATE REPORTED THAT THE BI IN THE SUBSEQUENT LOAD WAS NEGATIVE. THE MACHINE HAD ITS ANNUAL PREVENTATIVE MACHINE SERVICE IN 2008. NO PROBLEM WAS FOUND AND MACHINE WORKED WITHIN SPECS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYCLESURE BIOLOGICAL INDICATOR BIOLOGICAL INDICATOR FRC ADVANCED STERILIZATION PRODUCTS NA 16181A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK STERRAD 200 DOUBLE DOOR