BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DANTEC CONCENTRIC NEEDLE ELECTRODE

    MDR report key: 7345106 · Received March 16, 2018

    Report

    Report Number
    3005581270-2018-00001
    Event Type
    Injury
    Date Received
    March 16, 2018
    Date of Event
    February 8, 2018
    Report Date
    March 12, 2018
    Manufacturer
    NATUS MANUFACTURING LIMITED
    Product Code
    IKT
    UDI-DI
    05704736002875
    PMA / PMN Number
    K112034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    WORK ORDER (B)(4) WAS REVIEWED. RUN AT RISK 180 NOTED FOR RETEST OF ENVIRONMENTAL MONITORING CARRIED OUT IN THE CLEANROOM. IN PROCESS TESTING AND INSPECTIONS WERE REVIEWED - HUB TO COVER RETENTION TEST READINGS RANGING BETWEEN 1.215 - 6.580 KGF, HUB TO CANNULA TENSILE TEST RANGING FROM 21.13 - 32.98 IBF. RESULTS: ALL RESULTS WERE ACCEPTABLE AND RECORDED ON (B)(4). THE FOLLOWING TESTS WERE COMPLETED ON A QTY OF 7 NEEDLES (RETAINS) AS PER (B)(4) REV D: HUB TO COVER RETENTION TEST: RANGING BETWEEN 2.560 - 4.750 KGF - RESULTS: PASS. HUB TO CANNULA TENSILE TEST RANGING BETWEEN 23.77 - 30.98 IBF - RESULTS: PASS. CUSTOMER COMPLETED THE QUESTIONNAIRE AND PROVIDED FURTHER INFORMATION. MANUFACTURING ENGINEER HAS REVIEWED CUSTOMER RESPONSE AND HAS CONCLUDED: RESULTS: "COLOUR COVER SEPARATION AFTER PROCEDURE WHEN PULLING THE CABLE CONNECTOR OFF THE NEEDLE. PROBLEM WITH COLOUR COVER TOO LOSE OR CONNECTOR TOO TIGHT." PRODUCT RETURN REQUESTED FROM THE CUSTOMER BUT THE CUSTOMER HAS ALREADY DISPOSED OF THE DEFECTIVE PART. RESULTS: PROBLEM DEVICE NOT RETURNED, NO FURTHER INVESTIGATION COULD BE CARRIED OUT. NO FURTHER INFORMATION OBTAINED FROM THE CUSTOMER. COMPLAINT CLOSED TO CAPA(B)(4).

    Additional Manufacturer Narrative · 1

    MANUFACTURERS INITIAL INVESTIGATION: WORK ORDER (B)(4) WAS REVIEWED. RUN AT RISK 180 NOTED FOR RETEST OF ENVIRONMENTAL MONITORING CARRIED OUT IN THE CLEANROOM. IN PROCESS TESTING AND INSPECTIONS WERE REVIEWED - HUB TO COVER RETENTION TEST READINGS RANGING BETWEEN 1.215 - 6.580 KGF, HUB TO CANNULA TENSILE TEST RANGING FROM 21.13 - 32.98 IBF. ALL RESULTS WERE ACCEPTABLE AND RECORDED ON (B)(6). THE FOLLOWING TESTS WERE COMPLETED ON A QTY OF 7 NEEDLES (RETAINS) AS PER (B)(6) REV D: HUB TO COVER RETENTION TEST: RANGING BETWEEN 2.560 - 4.750KGF - PASS. HUB TO CANNULA TENSILE TEST RANGING BETWEEN 23.77 - 30.98 IBF - PASS. CUSTOMER COMPLETED THE QUESTIONNAIRE AND PROVIDED FURTHER INFORMATION. MANUFACTURING ENGINEER HAS REVIEWED CUSTOMER RESPONSE AND HAS CONCLUDED: "COLOUR COVER SEPARATION AFTER PROCEDURE WHEN PULLING THE CABLE CONNECTOR OFF THE NEEDLE. PROBLEM WITH COLOUR COVER TOO LOSE OR CONNECTOR TOO TIGHT." PRODUCT RETURN REQUESTED FROM THE CUSTOMER BUT THE CUSTOMER HAS ALREADY DISPOSED OF THE DEFECTIVE PART. CUSTOMER HAS BEEN CONTACTED TO PROVIDE THE REST OF THE REQUIRED INFORMATION BELOW BUT THE FOLLOWING INFORMATION HAS NOT BEEN PROVIDED TO US. PATIENT WEIGHT, CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES (EXCLUDING TREATMENT OF EVENT), CUSTOMER HAS CONFIRMED THAT THERE WAS NO OTHER RELEVANT DATA IN RELATION TO OTHER RELEVANT HISTORY, INCLUDING PRE-EXISTING MEDICAL CONDITIONS. JUSTIFICATION FOR NOT PROVIDING BELOW INFORMATION AND APPLICABLE SECTIONS: 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. 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 21 USC 360I(F).

    Description of Event or Problem · 1

    PART NUMBER: 9013S0032 DANTEC CONCENTRIC NEEDLE, LOT: 44B/17/D - NEEDLE DISENGAGED AND THE DOCTOR WAS HURT. IN TRYING TO DISCONNECT THE EMG NEEDLE FROM THE CABLE WITH THE THUMB AND INDEX FINGER, THE PLASTIC OF THE COVER ASSEMBLY SLIPPED OVER THE SOLID PARTS OF THE NEEDLE CRANIALLY, THEREBY A STITCH IN THE THUMB OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189057 DANTEC CONCENTRIC NEEDLE ELECTRODE DANTREC DISPOSABLE CONCENTRIC NEEDLE IKT NATUS MANUFACTURING LIMITED 9013S0032 44B/17/D 05704736002875

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other