BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DANTEC NEEDLE ELECTRODE

    MDR report key: 6401869 · Received March 14, 2017

    Report

    Report Number
    3005581270-2017-00004
    Event Type
    Injury
    Date Received
    March 14, 2017
    Report Date
    September 15, 2016
    Manufacturer
    NATUS MANUFACTURING LIMITED
    Product Code
    IKT
    PMA / PMN Number
    K931966
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION PROVIDED BELOW REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. THE LOT HISTORY RECORD WILL BE REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THIS PRODUCT. CUSTOMER HAS ALSO BEEN CONTACTED TO PROVIDE THE REST OF THE REQUIRED INFORMATION BELOW . THE FOLLOWING INFORMATION HAVE NOT BEEN PROVIDED AND HAVE BEEN NOTED BY THE CUSTOMER AS NOT KNOWN. THERE HAS BEEN NO ADVERSE EVENT REPORTED FOR THE USE ON THE PATIENT. AS REPORTED, THE DOCTOR HAD A NEEDLE STICK. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES (EXCLUDES TREATMENT OF EVENT) - CUSTOMER RESPONSE: WE USE THESE NEEDLES EVERY DAY IN OUR EMG LAB AND HAVE NOT HAD ANY PROBLEM BEFORE NOR AFTER THIS INCIDENT. CUSTOMER HAS CONFIRMED THAT THERE WERE NO RELEVANT TESTS/LABORATORY DATA, INCLUDING DATES PERFORMED AND NO OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS. JUSTIFICATION FOR NOT PROVIDING BELOW INFORMATION AND APPLICABLE SECTIONS: SERIAL # - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE DOES NOT HAVE SERIAL # UNIQUE IDENTIFIER (UDI) # - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE DID NOT HAVE THE UDI# PRESENT ON THE LABELLING AT THE TIME OF MANUFACTURE IF IMPLANTED DATE (MM/DD/YYYY) - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IMPLANTABLE IF EXPLANTED DATE (MM/DD/YYYY) - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IMPLANTABLE REPROCESSOR NAME AND ADDRESS - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT A SINGLE-USE DEVICE THAT WAS REPROCESSED OR REUSED ON A PATIENT IF IND, GIVE PROTOCOL # - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IND ADVERSE EVENT TERM(S) - THIS SECTION IS NOT APPLICABLE TO MEDICAL DEVICES IF REMEDIAL ACTION INITIATED, CHECK TYPE - THIS SECTION IS NOT APPLICABLE AS NO REMEDIAL ACTION WAS INITIATED IF ACTION REPORTED TO FDA UNDER 21 USC 360I(F), LIST CORRECTION/REMOVAL REPORTING NUMBER - THIS SECTION IS NOT APPLICABLE AS THERE WAS NO ACTION REPORTED UNDER 21 USC 360I(F)

    Additional Manufacturer Narrative · 1

    MANUFACTURER NARRATIVE: NO ISSUES WITH THE PRODUCTION OF THIS LOT OF ELECTRODES. THE DEVICE WAS FOUND TO HAVE MET SPECIFICATIONS PRIOR TO SHIPMENT. VISUAL INSPECTION WAS CARRIED OUT ON 6 NEEDLES RETAINED FROM THE SAME LOT. THE NEEDLES WERE FOUND TO BE CORRECTLY INTACTED INSIDE THE PROTECTIVE TUBES. THE TUBES LOOKED UNBLEMISHED WITH NO VISUAL DEFECTS FOUND. POUCHES WERE ALSO FOUND TO BE ACCEPTABLE. ALL IN PROCESS INSPECTIONS AND TESTING WERE REVIEWED. NO MANUFACTURING ANOMALIES WERE IDENTIFIED THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THIS IS THE FIRST EVENT REPORTED FOR THIS LOT NUMBER TO DATE. PATIENT WAS SCREENED FOR COMMUNICABLE DISEASES AND HAD NONE, SO THE RESIDENT PHYSICIAN DID NOT REQUIRE FURTHER MEDICAL INTERVENTION. NO FURTHER HOSPITALISATION. THE PHYSICIAN DID NOT DEVELOP AN INFECTION. THE RESULT OF THE INVESTIGATION IS INCONCLUSIVE AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. CORRECTE DATA: REPROCESSOR NAME AND ADDRESS HAS BEEN FILLED OUT BY MISTAKE. THE DEVICE IS A SINGLE USE AND WAS NOT REPROCESSED AND REUSED ON A PATIENT. BELOW MANUFACTURER'S DETAILS ARE NOT APPLICABLE IN SECTION. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED WHEN THEY WERE PUTTING BACK THE DANTEC CONCENTRIC NEEDLE BACK INTO THE PLASTIC SLEEVE THE NEEDLE WENT THROUGH THE SLEEVE AND THEY GOT A NEEDLE STICK. THIS HAPPENED ON ONE OCCASION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187099 DANTEC NEEDLE ELECTRODE DANTEC DISPOSABLE CONCENTRIC NEEDLE ELECTRODE IKT NATUS MANUFACTURING LIMITED 9013S0012 23A/16/D

    Patients

    Seq Age Sex Outcome Treatment
    1 Other