BEUDAMED
    FDA Adverse Event Other Summary report: N

    TUNNELER

    MDR report key: 1943821 · Received December 21, 2010

    Report

    Report Number
    2026095-2010-00317
    Event Type
    Other
    Date Received
    December 21, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 22, 2010
    Manufacturer
    I-FLOW CORP.
    Product Code
    BSO
    PMA / PMN Number
    K063234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE RECEIVED FOR EVAL AND INVESTIGATION. WITHOUT THE ACTUAL PRODUCT OR LOT NUMBER, A COMPLETE ANALYSIS CANNOT BE CONDUCTED. NO ADDITIONAL INFO WAS AVAILABLE. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORD AND THE LOT HISTORY CANNOT BE REVIEWED. IF ADDITIONAL INFO PERTINENT TO THIS COMPLAINT OR THE SAMPLE IS RECEIVED, THE FILE WILL BE REOPENED.

    Description of Event or Problem · 1

    DURING REMOVAL OF THE TUNNELER SHEATH, IT WAS NOTED THAT PART WAS MISSING. SURGEON CHOSE TO CLOSE WITH THE TUNNELER TIP STILL INSIDE PT. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TUNNELER ACCESSORY BSO I-FLOW CORP. T17X8 ANP

    Patients

    Seq Age Sex Outcome Treatment
    1