BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DANTEC CONCENTRIC NEEDLE ELECTRODE

    MDR report key: 7784042 · Received August 15, 2018

    Report

    Report Number
    3005581270-2018-00007
    Event Type
    Malfunction
    Date Received
    August 15, 2018
    Date of Event
    July 2, 2018
    Report Date
    September 13, 2018
    Manufacturer
    NATUS MANUFACTURING LIMITED
    Product Code
    IKT
    UDI-DI
    05704736002875
    PMA / PMN Number
    K112034
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    WORK ORDER (B)(4) WAS REVIEWED. NO REWORK OR SORT PERFORMED ON THIS LOT. NO NCR'S NOTED. IN PROCESS TESTING AND INSPECTIONS RECORDED ON DOC-011247 REV F WERE REVIEWED. ALL SAMPLES TAKEN FOR TESTS GAVE PASS RESULTS. 2 X PRODUCTION RESTART FORMS DOC-011369 REV A WERE PRESENT IN RELATION TO THE SORTIMAT GRIPPERS ADJUSTMENT AND GRINDER FULL COOLANT CHANGE. ALL TESTS WERE CARRIED OUT FOR PRODUCTION TO RESTART AND BOTH WERE APPROVED BY ENGINEERING. 1 USED NEEDLE WAS RETURNED FOR INVESTIGATION. A VISUAL INSPECTION WAS COMPLETED, THE COMPLAINT IS CONFIRMED. PLASTIC COLOUR COVER SEPARATED FROM NEEDLE AND METAL HUB. CAVITY NUMBER OF THE COLOUR COVER IS 4A. NO FURTHER TESTING CAN BE CONDUCTED AS NEEDLE IS DISASSEMBLED. DOC-010782 RISK MANAGEMENT REPORT FOR DANTEC DCN WAS REVIEWED. POTENTIAL HAZARD AND HAZARDOUS SITUATION IDENTIFIED ASSOCIATED WITH PHYSICAL INJURY - NEEDLE STICK, ID 23 (NEEDLES ARE SHARP, USERS COULD PIERCE THEMSELVES) AND PHYSICAL INJURY - CANNULA & HUB ASSEMBLY SEPARATED FROM OUTER COLOUR COVER, ID 29 (USERS COULD PIERCE THEMSELVES). THE OVERALL RISK RATING IS 3A (LOW - GREEN AREA) (SEVERITY OF HAZARD - 3 - MODERATE, PROBABILITY OF HAZARD - A-UNLIKELY). THE COMPLAINT LOG WAS REVIEWED OVER 12 MONTHS, 6 SIMILAR COMPLAINTS NOTED FOR THIS PRODUCT LINE. CAPA003896 HAS BEEN OPENED TO INVESTIGATE FURTHER.

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD TO BE REVIEWED. DEFECTIVE PART REQUESTED TO BE RETURNED. FURTHER INFORMATION REQUESTED FROM THE CUSTOMER. PATIENT INFORMATION - NO PATIENT INJURY REPORTED, DEVICE MALFUNCTION OCCURRED. OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS: THIS SECTION IS NOT APPLICABLE AS NO PATIENT INJURY OCCURRED. SUSPECT PRODUCTS - NOT APPLICABLE. SERIAL # THE MEDICAL DEVICE DOES NOT HAVE A SERIAL NUMBER. THE MEDICAL DEVICE IS NOT IMPLANTABLE. THE MEDICAL DEVICE IS NOT A SINGLE-USE DEVICE THAT WAS REPROCESSED OR REUSED ON A PATIENT.

    Description of Event or Problem · 1

    HUB AND CANNULA SEPARATION FROM COLOUR COVER DURING REMOVAL OF CONNECTOR CABLE. "WHEN PULLING OUT THE EMG NEEDLE, THE PLASTIC SOCKET WILL DETACH AT THE CONNECTION OF EMG NEEDLE TO LEAD CABLE, THEREBY UNCONTROLLABLE NEEDLE MOVEMENT AND RISK OF INJURY TO USERS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628391 DANTEC CONCENTRIC NEEDLE ELECTRODE DANTEC DISPOSABLE CONCENTRIC NEEDLE IKT NATUS MANUFACTURING LIMITED 9013S0032 27B/17/D 05704736002875

    Patients

    Seq Age Sex Outcome Treatment
    1 Other