BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HP TLC KIT 12 X 16CM CE

    MDR report key: 3301793 · Received August 7, 2013

    Report

    Report Number
    1317749-2013-00255
    Event Type
    Malfunction
    Date Received
    August 7, 2013
    Date of Event
    July 5, 2013
    Report Date
    July 31, 2013
    Manufacturer
    COVIDIEN
    Product Code
    NKQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(4). 2013 THAT A CUSTOMER HAD AN ISSUE WITH HP TLC KIT 12 X 16CM CE. THE CUSTOMER STATES THAT THEY ATTEMPTED RIGHT FEMORAL MAHURKAR LINE PLACEMENT WITH ULTRASOUND GUIDANCE. PT WAS IN THE SUPINE DURING INSERTION, NO ABNORMAL RESISTANCE OR DIFFICULTY ENCOUNTERED WITH ADEQUATE RETURN OF VENOUS BLOOD VISUALIZED. NUMEROUS ATTEMPTS TO REMOVE THE GUIDE WIRE FAILED; UNABLE TO REMOVE THE GUIDE WIRE. CATHETER WAS REMOVED, LEAVING THE GUIDE WIRE IN. VISUALIZED WITH C-ARM, IT APPEARED KINKED. PT WAS TAKEN TO INTERVENTIONAL RADIOLOGY FOR REMOVAL. NO COMPLICATIONS TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371366 HP TLC KIT 12 X 16CM CE HP TLC KIT 12 X 16CM CE NKQ COVIDIEN 8888345629HP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK