BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEBBETTS FIBEROPTC SS RETR 9CMX24MM BLDE

    MDR report key: 2262190 · Received September 23, 2011

    Report

    Report Number
    1038548-2011-00019
    Event Type
    Injury
    Date Received
    September 23, 2011
    Date of Event
    March 25, 2010
    Report Date
    September 22, 2011
    Manufacturer
    CAREFUSION
    Product Code
    FDJ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    "CAREFUSION MEDICAL DEVICE COMPLAINTS WERE PREVIOUSLY HANDLED BY CARDINAL HEALTH UNDER A TRANSITIONAL SERVICE AGREEMENT FROM (B)(6) 2009 UNTIL (B)(6) 2011. IN RETROSPECTIVE REVIEW BY CAREFUSION REPRESENTATIVES, IT WAS DETERMINED THAT THIS EVENT NECESSITATES SUBMISSION AS AN MDR IN ADHERENCE WITH THE FEDERAL CODES OF REGULATION." THE DEVICE WAS NOT RECEIVED FOR EVALUATION. AN ATTEMPT TO CONTACT THE END USER/CUSTOMER FOR MORE INFORMATION WAS MADE, AND THE CUSTOMER COULD NOT BE REACHED. A LOT NUMBER WAS NOT PROVIDED AND THE DEVICE WAS NOT AVAILABLE FOR EVALUATION, A DHR REVIEW COULD NOT BE PERFORMED. ROOT CAUSE: USER ERROR - USE OF THE INCORRECT LIGHT CABLE SIZE, PRODUCT LABELING STATES THAT THE DEVICE IS FOR USE WITH A 3.5MM FIBER-OPTIC CABLE ONLY. HISTORICAL CORRECTIVE ACTION SUMMARY: IN (B)(6) 2009 EVERY CUSTOMER WITH RECORD OF PURCHASE OF THE SUBJECT DEVICE FROM (B)(6) 2007 - (B)(6) 2009 WAS PROVIDED WITH A MARKETING BULLETIN CONCERNING THE PROPER CARE, HANDLING AND USE OF THESE DEVICES, PARTICULARLY THE NEED TO USE THE DEVICE WITH A 3.55MM SIZED CABLE ONLY. IN ADDITION, EACH CUSTOMER WAS PROVIDED WITH A SUPPLEMENTAL IFU (SEE ITEM #3 BELOW FOR DETAILS). IN (B)(6) 2009 A TRAINING PROGRAM WAS ADMINISTERED TO ALL SALES REPRESENTATIVES OF THE COMPANY ENGAGED IN SELLING THESE DEVICES TO ENABLE APPROPRIATE CUSTOMER SUPPORT AND IN-SERVICE, AS APPROPRIATE. CREATION OF A SUPPLEMENTAL IFU FOR INCLUSION IN THE DEVICE LABELING BEGINNING IN (B)(6) 2009, FOLLOWED BY A FULLY UPDATED AND SIX LANGUAGE TRANSLATED IFU ISSUED IN (B)(6) 2009. THESE IFUS WERE UPDATED TO INCLUDE A WARNING STATEMENT TO ENSURE THE USE OF THE PROPER 3.5MM FIBER OPTIC CABLE WITH THE DEVICE AND INCLUDED SEVERAL CAUTION STATEMENTS HIGHLIGHTING THE PROPER USE AND CARE OF THE DEVICE. (B)(4)

    Description of Event or Problem · 1

    MISUSE OF PRODUCT CUSTOMER STATES THEY CONNECTED CABLE TO WRONG PORT ON LIGHT SOURCE SO REALIZED THEIR ERROR BUT CAUSED PATIENT BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEBBETTS FIBEROPTC SS RETR 9CMX24MM BLDE SNARE, RIGID SELF-OPENING FDJ CAREFUSION 88-1087 NO LOT GIVEN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention