BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMITH MEDICAL

    MDR report key: 2598331 · Received March 26, 2012

    Report

    Report Number
    2598331
    Event Type
    Injury
    Date Received
    March 26, 2012
    Date of Event
    March 20, 2012
    Report Date
    March 23, 2012
    Manufacturer
    SMITH MEDICAL
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RESPIRATORY THERAPIST WAS REPLACING RIGHT RADIAL ARTERIAL LINE. UPON INSERTING CATHETER AND REMOVE NEEDLE, THE SHEATH (CATHETER) FRACTURED. PIECE OF CATHETER REMAINED UNDER SKIN. ATTEMPTS TO REMOVE OBJECT NOT SUCCESSFUL. ON (B)(6) 2012, TAKE TO OPERATING ROOM - REMOVAL OF FOREIGN BODY AND THROMBECTOMY. PATH #12-0003851 NOTED 1.7 CM X 0.2 CM PLASTIC OBJECT REMOVED. SEE SCANNED PAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMITH MEDICAL JELCO IV CATHETER FOZ SMITH MEDICAL 4059 1864565

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention