BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICTH VSYS/PRT/LCK 4NDL LWPF

    MDR report key: 3084857 · Received April 25, 2013

    Report

    Report Number
    1219930-2013-00309
    Event Type
    Injury
    Date Received
    April 25, 2013
    Date of Event
    March 29, 2013
    Report Date
    March 29, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    LJT
    PMA / PMN Number
    K952748
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: CHEMOSITE INSERTION. ACCORDING TO THE REPORTER: CUSTOMER STATES THAT PORT-A WAS BLOCKING. MEDICAL INTERVENTION REQUIRED; SURGERY TIME EXTENDED; PRODUCT NOT TESTED PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178414 MINICTH VSYS/PRT/LCK 4NDL LWPF INFUSION PORT PRODUCT LJT COVIDIEN, FORMERLY US SURGICAL N1L0465L

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other