BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PTM TITA JET LIGHT II INFUSAPORT

    MDR report key: 2725620 · Received August 28, 2012

    Report

    Report Number
    2725620
    Event Type
    Injury
    Date Received
    August 28, 2012
    Date of Event
    August 21, 2012
    Report Date
    August 27, 2012
    Manufacturer
    PFM MEDICAL INC.
    Product Code
    LJT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INFUSAPORT CATHETER PLACED ON (B)(6) 2012, IN INTERVENTIONAL RADIOLOGY. ON (B)(6) 2012, THE CATHETER WAS FOUND DETACHED AND THE LOCKING MECHANISM WAS STILL ON THE RESERVOIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PTM TITA JET LIGHT II INFUSAPORT INFUSAPORT CATHETER LJT PFM MEDICAL INC. 120307000

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention