BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRAOSSEOUS INFUSION NEEDLE

    MDR report key: 3902216 · Received June 24, 2014

    Report

    Report Number
    1820334-2014-00279
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    February 25, 2014
    Report Date
    May 27, 2014
    Manufacturer
    COOK, INC.
    Product Code
    FMI
    PMA / PMN Number
    K913258
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT WITH CARDIOGENIC SHOCK UNDERWENT OSTEOLYSIS OF THE RIGHT LEG ON (B)(6) 2014. AS THE ION WAS BEING INTRODUCED THE PLASTIC WINGS BROKE LEAVING THE NEEDLE INTO BONE. NEEDLE WAS RETRIEVED WITH A KELLY AND PLIERS. PROCEDURE WAS COMPLETED WITH A NEW OSTEOLYSIS NEEDLE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367931 INTRAOSSEOUS INFUSION NEEDLE FMI NEEDLE, HYPODERMIC, SINGLE LUMEN FMI COOK, INC. NA 4153815

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO Other| R