BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAY SKIN PREP DRY W/SPONGE

    MDR report key: 2413483 · Received January 12, 2012

    Report

    Report Number
    8030673-2012-00072
    Event Type
    Malfunction
    Date Received
    January 12, 2012
    Date of Event
    December 2, 2010
    Report Date
    January 12, 2012
    Manufacturer
    CAREFUSION
    Product Code
    OJU
    PMA / PMN Number
    K781797
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CAREFUSION 2200 INC. POST-MARKET SURVEILLANCE WAS HISTORICALLY MANAGED BY CARDINAL HEALTH VIA A TRANSITIONAL SERVICE AGREEMENT FROM SEPTEMBER 1, 2009, THROUGH JULY 1, 2011, SINCE CAREFUSION OFFICIALLY SPUN OFF FROM CARDINAL HEALTH AS OF SEPTEMBER 1, 2009. A RETROSPECTIVE REVIEW OF ALL COMPLAINTS DURING THIS TIMEFRAME WAS CONDUCTED BY THE NEW CAREFUSION CUSTOMER ADVOCACY CLINICAL TEAM IN ACCORDANCE WITH INTERNAL STANDARD OPERATING PROCEDURES AND IT WAS DETERMINED THAT THIS EVENT NECESSITATES SUBMISSION AS A MEDICAL DEVICE REPORTABLE (MDR) IN ACCORDANCE WITH 21 CODE OF FEDERAL REGULATION (CFR) PART 803.

    Description of Event or Problem · 1

    THE SURGEON WAS PREPARING THE PATIENT WITH THE SPONGE STICK FROM PREOPERATIVE TRAY. THE SPONGE SEPARATED FROM THE STICK UPON INSERTION INTO THE VAGINA. THIS WAS NOT APPARENT AT THE TIME AND THE DOCTOR SCRUBBED WITH THE SPONGE STICK. WHEN THE SPONGE STICK WAS REMOVED IT WAS IMMEDIATELY NOTICED THAT THE SPONGE REMAINED IN THE VAGINA. THE SPONGE WAS PROMPTLY REMOVED AND THE PREPARATION WAS CONTINUED WITH THE REMAINING SPONGE STICKS WITHOUT ANY PROBLEMS. THERE WERE THREE SCRATCHES IN THE VAGINA. UNFORTUNATELY, THERE IS NO SAMPLE AVAILABLE FOR EVALUATION. HOWEVER SAMPLES OUR CURRENT PROCESS WAS PERFORMED A PULL TEST. THE DEVICE HISTORY RECORD FOR THE LOT REPORTED WAS EVALUATED FOR ANY ISSUES RELATED WITH THIS CUSTOMER REPORT. THE PRODUCT WAS MANUFACTURED, INSPECTED AND RELEASED IN ACCORDANCE WITH OUR INTERNAL PROCEDURES AND NO ISSUES WERE OBSERVED. IN ADDITION, THE SUBASSEMBLIES 09S03583 (CONTOUR STICK SPONGE) AND 09S03987 ( SQUARE STICK SPONGE) WERE REVIEWED AND NO PROBLEMS WERE FOUND RELATED WITH THE ISSUE REPORTED. THE SEAL PARAMETERS WERE FOUND WITHIN SPECIFICATIONS. AT THIS TIME THE CONTOUR STICK SPONGE IS NOT BEING MANUFACTURED, HOWEVER WE COULD OBSERVE IN OUR MANUFACTURING AREA THAT THE PRE-ASSEMBLY OPERATION BETWEEN THE STICK AND CONTOUR SPONGE IS PERFORMED IN WORK TABLES IN THE SAME WORKSTATION WHERE THE SEAL EQUIPMENT WAS PLACED, PROBABLY CAUSING UNSEALED AND SEALED CONTOUR STICK SPONGES TO GET MIXED. THE SQUARE STICK SPONGE IS SEALED IN ROULETTE EQUIPMENT, IN ONE SIDE IS PLACED THE PRE-ASSEMBLY SQUARE STICK SPONGE (UNSEAL) AND IN THE OPPOSITE SIDE THE SEAL SQUARE STICK SPONGE IS TAKEN BY AN OPERATIVE PERSONNEL MAKING A MIXTURE OF THIS STICK SPONGES LESS PROBABLE. AT THIS TIME IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE TO THE ISSUE REPORTED. HOWEVER REVIEWING PROCESSES OF SQUARE AND CONTOUR STICK SPONGE WE DETERMINED THE FOLLOWING: A POSSIBLE ROOT CAUSE FOR CONTOUR STICK SPONGES FELL OFF IS THAT OUR OPERATIVE PERSONNEL MIXED THE PRE-ASSEMBLY OF CONTOUR STICK SPONGE (UNSEALED) WITH THE SEAL STICK SPONGES DURING THE MANUFACTURING PROCESS. ABOUT THE SQUARE STICK SPONGE DURING THE SEAL OPERATION IT IS NOT POSSIBLE TO MIX THE SUBASSEMBLY DUE IN ONE SIDE IS PLACED THE PRE-ASSEMBLY SQUARE STICK SPONGE (UNSEALED) AND IN THE OPPOSITE SIDE THE SEAL SQUARE STICK SPONGE IS TAKEN BY AN OPERATIVE PERSONNEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAY SKIN PREP DRY W/SPONGE APPLICATOR, ABSORBENT TIPPED, STERILE OJU CAREFUSION 4461A Y10N1777

    Patients

    Seq Age Sex Outcome Treatment
    1