BEUDAMED
    FDA Adverse Event Other Summary report: N

    MICROTARGETING INSERTION TUBE

    MDR report key: 2564052 · Received May 1, 2012

    Report

    Report Number
    3005677147-2012-00003
    Event Type
    Other
    Date Received
    May 1, 2012
    Date of Event
    April 5, 2012
    Report Date
    April 5, 2012
    Manufacturer
    FHC, INC
    Product Code
    HAW
    PMA / PMN Number
    K092562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IN-HOUSE RISK ANALYSIS WAS PERFORMED ON THE LABEL WORDING AND THE RISK TO THE PT WAS DEEMED LOW AS THE LABELS ON THE EXTERIOR 5 PACK AND THE INDIVIDUAL PACKS WERE CORRECT, I.E. "2 OUT OF 3 LABELS ON THE PACKAGE WERE CORRECT", SO BY THE TIME THE USER FACILITY REVIEWED THE POUCH LABEL OF THE PRODUCT, AWARENESS OF THE CONTENTS OF THE PRODUCT AND ITS INTENDED USE HAD PREVIOUSLY BEEN DETERMINED BY THE USER. AN ENGINEERING CHANGE WAS OPENED AND THE LABEL CORRECTION WAS IMPLEMENTED IMMEDIATELY. FHC WOULD LIKE TO NOTE THAT NO INCIDENT REPORTS REGARDING THIS ISSUE HAVE BEEN RECEIVED FROM THE FIELD.

    Description of Event or Problem · 1

    FHC'S PRODUCTION DEPARTMENT REPORTED A MISLABELLED POUCH LABEL FOR AN ARRAY INSERTION TUBE DURING FINAL STEPS OF PRODUCTION. THE INCORRECT LABEL NOTED "STAR ARRAY ELECTRODE INSERTION TUBE WITH STYLET 1X FOR USE WITH MICROTARGETING PLATFORM CONTAINS: (1) ARRAY INSERTION GUIDE TUBE, (1) ARRAY ELECTRODE" INSTEAD OF "STAR ARRAY ELECTRODE INSERTION TUBE WITH STYLET 1X FOR USE WITH MICROTARGETING PLATFORM CONTAINS: (1) ARRAY INSERTION GUIDE TUBE, (1) ARRAY ELECTRODE INSERTION TUBE, (1) STYLET" IT WAS DETERMINED THAT THE LABEL HAD BEEN INCORRECT SINCE 2009 WHEN THE TUBES WERE INTRODUCED IN THE MARKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROTARGETING INSERTION TUBE INSERTION TUBE HAW FHC, INC 3026871

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK