BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFETY SPONGE SYSTEM

    MDR report key: 2771685 · Received September 28, 2012

    Report

    Report Number
    3005868511-2012-00007
    Event Type
    Malfunction
    Date Received
    September 28, 2012
    Date of Event
    August 30, 2012
    Report Date
    August 30, 2012
    Manufacturer
    SURGICOUNT MEDICAL INC.
    Product Code
    GDY
    PMA / PMN Number
    K060076
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A PICTURE OF THE DEFECTIVE SPONGE SAMPLE WAS RECEIVED AND IT WAS CONFIRMED THAT PARTS OF THE DMT LABEL DID SEPARATE FROM THE SPONGE. USER CONFIRMED THAT THE SPONGE WAS NEITHER PRE-TREATED IN SALINE WARMER NOR WAS IT EXPOSED TO SURGICAL CONDITIONS OUT OF ORDINARY. DMT LABELS HAVE BEEN TESTED IN ACCORDANCE WITH ISO 10993-1 REQUIREMENTS FOR LONG TERM IMPLANTATION (>30 DAYS) AND ALL TESTS HAVE PASSED. EXTENSIVE TESTING OF INVENTORY FOR DMT LABEL ADHESION BEFORE AND AFTER SOAKING IN SALINE AT ELEVATED TEMPERATURE (>110OF) HAS BEEN CONDUCTED AND HAVE MET ACCEPTANCE CRITERIA. COMPLIANCE WITH VALIDATION CRITERIA, REVALIDATION SCHEDULES, AND MAINTENANCE CHECKS OF HEAT SET MACHINES USED TO APPLY DMT LABELS TO SPONGES HAVE BEEN VERIFIED AND AS A OF JANUARY OF THIS YEAR, DMT LABEL SUPPLIER PROCESSES HAVE BEEN REVISED TO BETTER CONTROL DMT HEAT SENSITIVE ADHESIVE APPLICATION. (B)(4). SURGICOUNT MEDICAL CONSIDERS THIS TO BE A FINAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING COUNT-OUT, A SPONGE WAS IDENTIFIED WITH AN UNREADABLE BARCODE AND THE SPONGE SERIAL NUMBER WAS NOT LEGIBLE. HOWEVER, AFTER EXAMINING THE PICTURES OF THE DEFECTIVE SPONGE, IT WAS FOUND THAT PARTS OF THE DATA MATRIX TAG (DMT) LABEL WERE SEPARATED FROM THE SPONGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFETY SPONGE SYSTEM NON-ABSORBABLE GAUZE, INTERNAL (GDY) GDY SURGICOUNT MEDICAL INC. SM-1818-PS 403931

    Patients

    Seq Age Sex Outcome Treatment
    1