BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYCLESURE BIOLOGICAL INDICATOR

    MDR report key: 1032734 · Received April 22, 2008

    Report

    Report Number
    2084725-2008-00132
    Event Type
    Malfunction
    Date Received
    April 22, 2008
    Date of Event
    March 25, 2008
    Report Date
    March 25, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN EMPLOYEE WHO CRUSHED A BIOLOGICAL INDICATOR (BI) THAT "RUPTURED" AND "PIERCED" HER RIGHT INDEX FINGER. THE EMPLOYEE WASHED THE CONTACT AREA WITH "CHOLORHEX" SOAP. THE EMPLOYEE DID NOT SEEK MEDICAL ATTENTION OR RECEIVE TREATMENT FOR THE CONTACT. ATTEMPTED TO F/U WITH THE CUSTOMER TO GATHER INFO ABOUT WHETHER OR NOT THE EMPLOYEE WAS USING THE PROVIDED VIAL CRUSHER WHEN THE INCIDENT OCCURRED, THE CUSTOMER WAS NOT AVAIL. REQUESTED THAT THE CUSTOMER RETURN THE DEVICE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYCLESURE BIOLOGICAL INDICATOR INDICATOR, BIOLOGICAL FRC AVAIL MEDICAL PRODUCTS 14324 01181Z

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK