BEUDAMED
    FDA Adverse Event Summary report: N

    SCRUB TRAY, 8 GAUZE 4X4'S +

    MDR report key: 2943363 · Received February 5, 2013

    Report

    Report Number
    8030673-2013-00006
    Date Received
    February 5, 2013
    Date of Event
    January 8, 2013
    Report Date
    February 15, 2013
    Manufacturer
    CAREFUSION
    Product Code
    OJU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): SAMPLE IS NOT AVAILABLE, HOWEVER, PICTURES WERE SENT FOR REVIEW WHERE IT IS OBSERVED THE SLIT ON THE SPONGE TOP, NEVERTHELESS THIS IS HOW THE SPONGE WAS DESIGNED. ALSO ACCORDING TO CODE REPORTED AND PICTURES IS NOTED THAT A SQUARTER SPONGE WAS USED FOR VAGINAL PROCEDURE HOWEVER CAREFUSION PRODUCED A PREP KIT DESIGNED FOR VAGINAL PROCEDURES CODE 4469A, WHERE THE SPONGE IS A CONTOURED SHAPE TO AVOID SCRATCHES AS REPORTED IN THIS INCIDENT. NO LOT NUMBER WAS PROVIDED, AT THIS TIME IS NOT POSSIBLE TO REVIEW THE DEVICE HISTORY RECORD OF THE AFFECTED CODE 4437 PERSONNEL DOES NOT CONTRIBUTE TO FAILURE REPORTED, THE SLIT FOUND BY CUSTOMER IS HOW THE SPONGE IS DESIGN. DURING MANUFACTURING PROCESS NO ISSUES WERE OBSERVED, IN ADDITION FAILURE REPORTED BY CUSTOMER IS NOT CAUSED IN OUR PROCESS. NO ISSUES WITH THE MATERIALS DURING THE INVESTIGATION OF THIS INCIDENT THERE WAS NOT ANY ROOT CAUSE IDENTIFIED, PRODUCT IS RUNNING IN ACCORDANCE WITH OUR PROCEDURES. IN ADDITION IN ACCORDANCE WITH OUR CUSTOMER FEEDBACK HE USED A SQUARE STICK SPONGE FOR A VAGINAL PROCEDURE EVEN WHEN THIS TYPE OF SPONGE IS NOT DESIGNED FOR THAT USE, ACTUALLY WE HAVE ANOTHER CODE 4469A WHICH HAS A CONTOURED STICK SPONGE FOR VAGINAL PROCEDURES NO CORRECTIVE ACTION PLAN IS DETERMINED FOR THIS INCIDENT.

    Additional Manufacturer Narrative · 1

    (B)(4), THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    SPONGE HANDLE SCRATCHED A PATIENT. INFORMATION RECEIVED ON (B)(6) 2013 FROM MEDWATCH RECEIVED BY CAREFUSION NUMBER (B)(4): THE CUSTOMER REPORTED AS A PATIENT SAFETY CONCERN. IN THE DRY GAUZE PREOPERATIVE SKIN PREP TRAYS THERE ARE YELLOW SPONGE STICKS THAT ARE USED FOR VAGINAL PREPS IN THE OPERATING ROOM. THESE SPONGE STICKS ARE DESIGNED WITH A SLIT IN THE TOP. WHAT THE OPERATING ROOM STAFF AND SURGEONS ARE CONCERNED WITH IS WHEN THE SPONGE IS INSERTED IN TO THE VAGINAL CAVITY THAT THE SPONGE PUSHES BACK EXPOSING THE PLASTIC STICK AND THIS HAS BEEN REPORTED TO CAUSE ABRASIONS OR LACERATIONS. IT WAS REPORTED THAT THESE TYPES OF EVENTS HAVE OCCURRED IN THE PAST. OPERATING STAFF STATED THAT A LACERATION OCCURRED TO THIS PATIENT WITH THIS STAFF ARE VOICING CONCERNS WITH THE DESIGN OF THE DEVICE RELATED TO PATIENT SAFETY. FOLLOW UP INFORMATION RECEIVED FROM THE FACILITY (B)(4) 2013: THE PATIENT WAS UNDERGOING A SYNTHETIC SLING PLACEMENT. THE PATIENT DID NOT REQUIRE ANY INTERVENTION THE PATIENT ACTUALLY HAD A SCRATCH NOT A LACERATION. THE PROCEDURE CONTINUED AS PLANNED AND THE PATIENT DID NOT REQUIRE ANY ADDITIONAL FOLLOW UP RELATED TO THE EVENT. THE DEVICE IS NOT AVAILABLE FOR EVALUATION HOWEVER, PICTURES ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48283 SCRUB TRAY, 8 GAUZE 4X4'S + SKIN AND PREP TRAY OJU CAREFUSION 4437

    Patients

    Seq Age Sex Outcome Treatment
    1 Other