BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYCLESURE BIOLOGICAL INDICATOR

    MDR report key: 1032729 · Received April 22, 2008

    Report

    Report Number
    2084725-2008-00137
    Event Type
    Malfunction
    Date Received
    April 22, 2008
    Date of Event
    March 26, 2008
    Report Date
    March 26, 2008
    Manufacturer
    AVAIL MEDICAL PRODUCTS
    Product Code
    FRC
    PMA / PMN Number
    K994055
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PER INSTRUCTION FOR USE: "IF THE CYCLE CANCELS THE STERRAD CYCLESURE BI SHOULD BE AUTOCLAVED. A NEW STERRAD CYSLESURE BI SHOULD BE USED IN THE NEXT CYCLE.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED A CUSTOMER WITH SUSPECTED POSITIVE BIOLOGICAL INDICATOR (BI). THE CUSTOMER DID NOT RECALL ANY OF THE ITEMS FROM THE LOAD. THE CUSTOMER DID NOT PROVIDE INFO REGARDING POTENTIAL PT INJURY. THE AFFILIATE REPORTED THAT THE CUSTOMER DID NOT HAVE ANY ISSUES WITH THE LOAD RUN IN THE CYCLE. THE AFFILIATE REPORTED THAT THE CUSTOMER HAD USED THE BI IN A PREVIOUS CYCLE THAT CANCELLED. THE AFFILIATE REPORTED THAT RATHER THAN THROWING THE BI AWAY, THEY USED IT AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYCLESURE BIOLOGICAL INDICATOR INDICATOR, BIOLOGICAL FRC AVAIL MEDICAL PRODUCTS 14324 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK STERRAD 100S STERILIZATION SYSTEM