BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3M HEALTH CARE

    MDR report key: 747114 · Received October 27, 2005

    Report

    Report Number
    MW1037033
    Event Type
    Malfunction
    Date Received
    October 27, 2005
    Report Date
    October 27, 2005
    Manufacturer
    3M C/O REGAL SERVICES
    Product Code
    FRC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 7/26/05 IT WAS NOTICED DURING A ROUTINE INCUBATOR TEST BY THE LABORATORY, THAT THE "MEDIA" WAS NOT PRESENT IN THE "ATTEST STEAM PACK AMPULE" AS REQUIRED. IMMEDIATELY OUR LAB PERSONNEL NOTIFIED PERSONNEL IN THE SPD DEPARTMENT. THEN SPD EMPLOYEE NOTIFIED 3M SALES REP WHO MADE A WRITTEN REPORT TO 3M COMPANY. REP HAS RECENTLY STATED THAT IT WAS DETERMINED THAT THIS IS AN ISOLATED INCIDENT THAT HAPPENED AT OUR FACILITY AND AT ONE LOCATION. FIVE REPLACEMENT TEST PACKS WERE SENT OUT BY 3M. WE CURRENTLY HAVE FOUR DEFECTIVE AMPLUES ON HAND FOR REVIEW IF NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3M HEALTH CARE ATTEST STEAM PACK FRC 3M C/O REGAL SERVICES ATTEST 2007-04JA

    Patients

    Seq Age Sex Outcome Treatment
    1 *