BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2PC VEN SYS W/PRT LCK 4NDLE OD 2.5MM 9FR

    MDR report key: 4101528 · Received September 19, 2014

    Report

    Report Number
    1219930-2014-00844
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    January 20, 2014
    Report Date
    August 26, 2014
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    LJT
    PMA / PMN Number
    K961856
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: IMPLANT. ACCORDING TO THE REPORTER: THE CATHETER BROKE INSIDE PATIENT'S BODY AND MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584181 2PC VEN SYS W/PRT LCK 4NDLE OD 2.5MM 9FR INFUSION PORT LJT COVIDIEN, FORMERLY US SURGICAL A DIVISON 120044 N9L0253

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other