BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DANTEC CONCENTRIC NEEDLE ELECTRODE

    MDR report key: 8801571 · Received July 18, 2019

    Report

    Report Number
    3005581270-2019-00011
    Event Type
    Injury
    Date Received
    July 18, 2019
    Report Date
    September 12, 2019
    Manufacturer
    NATUS MANUFACTURING LTD
    Product Code
    IKT
    UDI-DI
    05704736002882
    PMA / PMN Number
    K143433
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    WORK ORDER 98057 WAS REVIEWED. APPROVED PQ135 AND PQ136 NOTED IN RELATION TO VALIDATION OF CONCENTRIC NEEDLES ON THE PENCIL POINT GRINDING PROCESS ON MC1917 AND FOR CONCENTRIC NEEDLES FOR MAIN BEVEL GRINDING PROCESS ON GRINDER MC1917 & ELECTRO POLISHER MC1901. ACCEPTED RUN AT RISK 180 - RELATED TO RETEST OF ENVIRONMENTAL MONITORING OF CLEANROOM. NO REWORK OR SORT PERFORMED ON THIS LOT. NO NCR'S RELATED TO THIS LOT. ALL IN PROCESS INSPECTIONS AND TESTING RECORDED ON DOC-011247 REV G WERE REVIEWED. ALL SAMPLES TAKEN FOR TESTS GAVE PASS RESULTS. THE RESULTS FOR HUB TO COVER RETENTION TEST WERE WITHIN SPECIFICATION WHICH IS MINIMUM 1.2KGF. LOWEST VALUE RECORDED WAS 1.710KGF, HIGHEST RECORDED VALUE WAS 6.325KGF.

    Additional Manufacturer Narrative · 1

    QUESTIONAIRE HAS BEEN SENT TO THE CUSTOMER TO OBTAIN MORE INFORMATION. RETAINS ARE READY FOR TESTING AND WORK ORDER WILL BE REVIEWED. DEFECTIVE PRODUCT HAS BEEN REQUESTED FOR INVESTIGATION. JUSTIFICATION FOR NOT PROVIDING BELOW INFORMATION AND APPLICABLE SECTIONS: PATIENT INFORMATION - NO PATIENT INJURY REPORTED, DEVICE MALFUNCTION OCCURRED. DATE OF EVENT - DATE OF EVENT REQUESTED FROM THE CUSTOMER BUT INFORMATION NOT YET PROVIDED RELEVANT TESTS / LABORATORY DATA - THIS SECTION IS NOT APPLICABLE AS NO PATIENT INJURY OCCURRED. OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS: THIS SECTION IS NOT APPLICABLE AS NO PATIENT INJURY OCCURRED. SUSPECT PRODUCTS - NOT APPLICABLE. SERIAL # - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE DOES NOT HAVE A SERIAL NUMBER. 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. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES (EXCLUDING TREATMENT OF EVENT) - THIS SECTION IS NOT APPLICABLE TO THIS TYPE OF DEVICE. FOR USE BY USER FACILITY / IMPORTER - NOT APPLICABLE AS WE ARE NOT A FACILITY OR IMPORTER OF DEVICE. IF ND, GIVE PROTOCOL # - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IND. ADVERSE EVENT TERMS - 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 21USC 360I(F).

    Description of Event or Problem · 1

    HUB TO COLOUR COVER SEPARATION INCIDENT. THE CUSTOMER NOTED THAT THERE WERE 3 INCIDENTS WITH THESE NEEDLES AND IN ONE INCIDENT (1-620443305), A PHYSICIAN RECEIVED A NEEDLE STICK. THERE HAS BEEN 3 COMPLAINTS OPENED TO DOCUMENT AND REPORT ALL 3 ISSUES: (B)(4) (3005581270-2019-00009). (B)(4) (3005581270-2019-00010). (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595803 DANTEC CONCENTRIC NEEDLE ELECTRODE DANTEC DISPOSABLE CONCENTRIC NEEDLE IKT NATUS MANUFACTURING LTD 9013S0042 47F/17/D 05704736002882

    Patients

    Seq Age Sex Outcome Treatment
    1 Other