BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECA ELITE NEEDLE

    MDR report key: 8165180 · Received December 14, 2018

    Report

    Report Number
    3005581270-2018-00017
    Event Type
    Malfunction
    Date Received
    December 14, 2018
    Date of Event
    September 8, 2018
    Report Date
    February 7, 2019
    Manufacturer
    NATUS MANUFACTURING LTD
    Product Code
    IKT
    UDI-DI
    00382830017503
    PMA / PMN Number
    K112034
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER HAS REPORTED 3 CASES. ON INITIAL REPORT IT WAS NOT KNOWN IF THE 3 CASES WERE OF THE SAME PART NUMBER AND LOT NUMBER, OR IF THE NEEDLES WERE USED ON THE SAME PATIENT OR 3 DIFFERENT PATIENTS. THIS INFORMATION WAS CLARIFIED BY THE CUSTOMER ON THE (B)(6) 2018. THE 3 INCIDENTS INVOLVED THE PART NUMBER S53156 AND LOT NUMBER 45B/17/T. THIS OCCURRED AFTER USE ON 3 DIFFERENT PATIENTS. THE THREE INCIDENTS WILL BE INVESTIGATED UNDER COMPLAINTS: · (B)(4) (AE NO. 3005581270-2018-00018), · (B)(4) ((AE NO. 3005581270-2018-00019). WORK ORDER (B)(4) WAS REVIEWED. NO NCR OR REWORK NOTED. APPROVED PRODUCTION RESTART FORM (B)(4) PRESENT IN RELATION TO THE GRINDER - FULL COOLANT CHANGE. APPROVED RUN AT RISK 179 AND 180 RELATED TO - RETEST OF ENVIRONMENTAL MONITORING CARRIED OUT IN THE CLEANROOM AND THE REFURBISHMENT OF THE MILLIPORE SYSTEM. ALL SAMPLES TAKEN FOR ASSEMBLY IN PROCESS TESTS GAVE ACCEPTABLE RESULTS AND WERE RECORDED ON (B)(4). READINGS FOR HUB TO COVER RETENTION TEST WERE WITHIN THE MINIMUM SPEC OF 1.2KGF RANGING BETWEEN 2.460KGF - 7.020KGF. (B)(4) RISK AND RISK MANAGEMENT REPORT - TECA DISPOSABLE NEEDLES AND VALUE DISPOSABLE NEEDLES AND VALUE LINE DCN WAS REVIEWED. THERE ARE TWO POTENTIAL HAZARDS AND HAZARDOUS SITUATIONS ASSOCIATED WITH PHYSICAL INJURY - NEEDLE STICK, ID 25 (NEEDLES ARE SHARP, USERS COULD PIERCE THEMSELVES) AND 31 (CANNULA & HUB ASSEMBLY SEPARATES FROM OUTER COLOR COVER). THE OVERALL RISK RATING IS 3A (SEVERITY OF HAZARD - 3- MODERATE, PROBABILITY OF HAZARD - A - UNLIKELY).

    Additional Manufacturer Narrative · 0

    CUSTOMER CONFIRMED NO PATIENT INJURY OCCURRED. THE FOLLOWING TEST WAS CARRIED OUT ON A QTY OF 10 NEEDLES (RETAINS): HUB TO COVER RETENTION TEST AS PER DOC-011097 REV Q - ALL NEEDLES PASSED WITH RESULTS WITHIN MINIMUM SPEC OF 1.2KGF. LOWEST VALUE RECORDED WAS 2.610KGF, HIGHEST RECORDED VALUE WAS 6.9200KGF. DEFECTIVE NEEDLES WERE RETURNED TO MIDDLETON HOWEVER THE DEFECTIVE PRODUCT WAS NOT RETURNED TO GORT FROM MIDDLETON. EMAIL HAS BEEN SENT TO THE MIDDLETON QA MANAGER TO MAKE THEM AWARE OF THE SITUATION, DUE TO THE DEFECTIVE NEEDLES NOT RETURNING TO GORT NATUS WAS UNABLE TO COMPLETE A FULL INVESTIGATION ON THE PARTS. CAPA (B)(4) OPENED TO INVESTIGATE THIS ISSUE FURTHER.

    Additional Manufacturer Narrative · 1

    CUSTOMER REPORTED 3 CASES WHERE HUB SEPARATION OCCURRED. IT IS NOT KNOWN IF THE 3 CASES WERE OF THE SAME PART NUMBER AND LOT NUMBER, OR IF THE NEEDLES WERE USED ON THE SAME PATIENT OR 3 DIFFERENT PATIENTS. THIS INFORMATION WILL BE CLARIFIED. JUSTIFICATION FOR NOT PROVIDING BELOW INFORMATION AND APPLICABLE SECTIONS: PART A: PATIENT INFORMATION - NO PATIENT INJURY INITIALLY REPORTED, DEVICE MALFUNCTION OCCURRED. THIS WILL BE CONFIRMED. DATE OF EVENT - DATE OF EVENT UNKNOWN, THIS INFORMATION WILL BE REQUESTED. 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 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 SEPARATION NEEDLE ISSUE. DEFECTIVE NEEDLES, THE PLASTIC PROTECTOR IS RELEASED WHEN THE CABLE IS DISCONNECTED AND THE NEEDLE REMAINS CONNECTED TO THE NEEDLE HOLDER. CUSTOMER HAS REPORTED 3 CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1006427 TECA ELITE NEEDLE TECA ELITE DISPOSABLE CONCENTRIC NEEDLE ELECTRODE, IKT NATUS MANUFACTURING LTD S53156 45B/17/T 00382830017503

    Patients

    Seq Age Sex Outcome Treatment
    1 Other