BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2PC VSYS W/9FR INTR KIT LW PFL

    MDR report key: 3587291 · Received October 9, 2013

    Report

    Report Number
    1219930-2013-00869
    Event Type
    Malfunction
    Date Received
    October 9, 2013
    Date of Event
    September 12, 2013
    Report Date
    September 16, 2013
    Manufacturer
    COVIDIEN, FORMERLY US
    Product Code
    LJT
    PMA / PMN Number
    K961856
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THERE WAS AN ABNORMAL SPLIT SHEATH. NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514322 2PC VSYS W/9FR INTR KIT LW PFL INFUSION PORT LJT COVIDIEN, FORMERLY US N2A0812

    Patients

    Seq Age Sex Outcome Treatment
    1