BEUDAMED
    FDA Adverse Event Injury Summary report: N

    D-FLEX TRIANGULAR RETRACTOR 80MM 5MM

    MDR report key: 4170232 · Received August 20, 2014

    Report

    Report Number
    1038548-2014-04146
    Event Type
    Injury
    Date Received
    August 20, 2014
    Date of Event
    July 29, 2014
    Report Date
    August 17, 2014
    Manufacturer
    CAREFUSION
    Product Code
    GCJ
    PMA / PMN Number
    K092684
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CAREFUSION RECEIVED A COMPLAINT FROM CARDINAL HEALTH (B)(4) THAT INDICATED A FACILITY WAS UTILIZING AN INCORRECT IFU (INSTRUCTIONS FOR USE) WHEN CLEANING/PROCESSING CAREFUSION DEVICES (89-6110). THE CORRECT IFU WAS PROVIDED WITH THE DEVICES AT THE TIME OF PURCHASE. ONE OF THE THREE DEVICES WAS RETURNED TO CAREFUSION FOR REPAIR/MAINTENANCE. (NOTE THAT THE REPAIR/MAINTENANCE IS NOT RELATED TO THIS COMPLAINT.) THE DEVICE WAS EVALUATED AND DID NOT SHOW ANY SIGNS OF BEING MODIFIED OR ALTERED. THE DEVICE WAS VISUALLY EXAMINED AND WAS DETERMINED TO REQUIRE REPAIR. THE DEVICE WAS SENT TO CAREFUSION'S IN-HOUSE REPAIR DEPARTMENT FOR INSPECTION AND REPAIR. THE CUSTOMER STATED THAT THEY INADVERTENTLY CLEANED THE DEVICES USING THE INCORRECT IFU. THIS RESULTED IN INCORRECT CLEANING/PROCESSING OF THE DEVICES, WHICH COULD CREATE A HARMFUL SITUATION FOR THE PATIENT DUE TO POTENTIAL BLOOD BORNE PATHOGEN EXPOSURE. THE FACILITY IS IN THE PROCESS OF TESTING (B)(4) PATIENTS FOR EXPOSURE AND ANY SUBSEQUENT DISEASE MANIFESTATION.

    Description of Event or Problem · 1

    AN EMAIL WAS RECEIVED FROM CARDINAL HEALTH (B)(4) 31JUL2014. IT STATED "THERE WAS AN ISSUE WITH HOW THE INSTRUMENTS WERE REPROCESSED. THEY WEREN'T FOLLOWING THE ORIGINAL IFU THAT WAS AVAILABLE WHEN THEY BOUGHT THE INSTRUMENTS IN 2012. THEY HAVE FOUND OUT WHEN THERE WAS SOME DEBRIS COMING OUT OF THE HANDLE. AS A PRECAUTION, THEY HAVE RECALLED ALL (B)(4) PATIENTS THAT THE INSTRUMENTS WAS USED ON SO THEY CAN BE TESTED FOR HEPATITIS. NONE SO FAR WERE POSITIVE. I'VE SENT THE NEW IFU (CF36-1828B_26-2904-C) AND THEY REVIEWED THEIR PROCEDURES. THEY ALSO HAD THEIR INSTRUMENTS INSPECTED AND REPAIRED BY SNOWDEN-PENCER (SEE DOCUMENTS)". THERE WAS NO PATIENT INJURY. THE PROCEDURE WAS A BARIATRIC SURGERY.: ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER 05AUG2014. IT WAS REPORTED THAT THE EXACT DATE OF INCIDENT IN 2012 WAS UNKNOWN. IT WAS JANUARY 2014 THAT THE FACILITY FIGURED OUT THEY WERE NOT CLEANING THE INSTRUMENT CORRECTLY PER THE IFU. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER 05AUGUST2014. THE LOT #'S FOR TWO OF THE RETRACTORS WAS C12R2. THE THIRD IS UNKNOWN BUT IS IN TRANSIT TO OUR MANUFACTURING FACILITY: ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER 12AUGUST2014. IT WAS REPORTED THAT THE FACILITY USED THE RETRACTORS ON (B)(4) PEOPLE THROUGH THE YEARS. THERE ARE NO POSITIVE RESULTS SO FAR FROM THE TESTING BEING CONDUCTED. THE FACILITY STILL HAS NOT REACHED (B)(4) OF THE PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500929 D-FLEX TRIANGULAR RETRACTOR 80MM 5MM LAPAROSCOPE, GENERAL & PLASTIC SURGERY/GCJ GCJ CAREFUSION 89-6110 C12R AND B11R1

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other NA/NA