BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIVER ACCESS AND BIOPSY SET

    MDR report key: 2833018 · Received October 31, 2012

    Report

    Report Number
    1820334-2012-00487
    Event Type
    Injury
    Date Received
    October 31, 2012
    Report Date
    October 3, 2012
    Manufacturer
    COOK, INC.
    Product Code
    FCG
    PMA / PMN Number
    K902319
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BLOOD PRODUCTS WERE GIVEN AS A PRECAUTIONARY MEASURE. INJURY TO PATIENT WAS NOT CONFIRMED. (B)(4). EVENT EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A PATIENT UNDERWENT A TRANSJUGULAR LIVER BIOPSY. THE NEEDLE WAS DROPPED ON THE FLOOR. ANOTHER KIT WAS GRABBED AND ONLY THE NEEDLE REMOVED. THE NEEDLE PROVIDED WAS ACTUALLY 70CM IN LENGTH AND NOT 60CM. INFORMATION RECEIVED FROM REP ON (B)(6) 2012: "I WAS TOLD THERE WAS NO EVIDENCE OF BLEEDING. THE PATIENT WAS GIVEN BLOOD PRODUCTS PROPHYLACTICLY TO BE SAFE. I WILL FIND OUT HOW MUCH WAS GIVEN. I BELIEVE IT WAS 1 UNIT BUT I WILL FOLLOW UP TO GIVE YOU A MORE DEFINITIVE ANSWER." HARM TO THE PATIENT WAS NOT CONFIRMED; HOWEVER, THE FACILITY HAS TAKEN PREVENTATIVE ACTION BY GIVING THE PATIENT HEMOGLOBIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIVER ACCESS AND BIOPSY SET FCG KIT, NEEDLE, BIOPSY FCG COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention