BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEEDLE, HYPODERMIC, SINGLE LUMEN

    MDR report key: 5476038 · Received March 3, 2016

    Report

    Report Number
    5476038
    Event Type
    Injury
    Date Received
    March 3, 2016
    Date of Event
    January 25, 2016
    Report Date
    February 1, 2016
    Manufacturer
    CAREFUSION 2200, INC.
    Product Code
    FMI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PROCEDURE WAS PERFORMED BY MED STUDENT. A POCKET WAS IDENTIFIED FOR PARACENTESIS WHICH WAS ABOUT 6CM DEEP AND ABOUT 4-5CM IN DEPTH. AFTER THE 25 GAUGE NEEDLE WAS INTRODUCED IN THE LEFT LOWER QUADRANT FOR LOCAL ANESTHESIA WE GOT PERITONEAL FLUID RETURN. AT THE POINT, WE DETACHED THE LIDOCAINE SYRINGE AND USED THE 55CC SYRINGE TO WITHDRAW PERITONEAL FLUID. UNFORTUNATELY, WHILE PULLING THE SYRINGE OUT, THE NEEDLE BROKE WITHIN THE SUBCUTANEOUS TISSUE. WE GOT AN ABDOMINAL X-RAY AFTER THE PROCEDURE THAT CONFIRMED THE PRESENCE OF THE NEEDLE IN THE SUBCUTANEOUS TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134561 NEEDLE, HYPODERMIC, SINGLE LUMEN FMI CAREFUSION 2200, INC. 25G X 1 1/2 (3.8CM) WITH SHARPS PROTECTION

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR