BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMETRA INTRATHECAL CATHETER

    MDR report key: 4213615 · Received October 24, 2014

    Report

    Report Number
    3006803715-2014-00036
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    September 16, 2014
    Report Date
    October 13, 2014
    Manufacturer
    FLOWONIX MEDICAL, INC
    Product Code
    LKK
    PMA / PMN Number
    P080012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CATHETER TORE WHEN THE PHYSICIAN TRIED TO PULL BACK THE CATHETER WITH THE TOUCHY NEEDLE STILL IN PLACE. A NEW CATHETER WAS USED TO COMPLETE THE PROCEDURE. THE TORN CATHETER WAS DISCARDED AND THERE WERE NO PT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678065 PROMETRA INTRATHECAL CATHETER IMPLANTABLE INTRATHECAL CATHETER LKK FLOWONIX MEDICAL, INC 11823 19413

    Patients

    Seq Age Sex Outcome Treatment
    1