BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DANTEC CONCENTRIC NEEDLE ELECTRODE

    MDR report key: 8146087 · Received December 10, 2018

    Report

    Report Number
    3005581270-2018-00014
    Event Type
    Injury
    Date Received
    December 10, 2018
    Date of Event
    November 28, 2018
    Report Date
    February 5, 2019
    Manufacturer
    NATUS MANUFACTURING LTD.
    Product Code
    IKT
    PMA / PMN Number
    K112034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    REQUESTED UPDATE ON THE DOCTOR, NO FURTHER UPDATE RECEIVED. VISUAL INSPECTION COMPLETED,THE DEFECT HUB AND NEEDLE WERE IN A PLASTIC BOTTLE, COMPLAINT CONFIRMED. PLASTIC COLOUR COVER SEPARATE FROM NEEDLE AND METAL HUB.. NO FURTHER TESTING CAN BE CONDUCTED AS NEEDLE IS A BIOHAZZARD. UNOPENED NEEDLES OF THE SAME LOT NUMBER AND THE DANTEC CABLE USED WITH THESE NEEDLES WAS ALSO RETURNED BY THE CUSTOMER. NATUS TESTED THESE AND THE RESULTS WERE AS FOLLOWS: RESULTS FOR SEPARATION FORCE: 475GF. RESULTS FOR HUB TO COVER RETENTION: 2.415KGF. ALL PARTS ARE WELL WITH IN SPECIFICATION. CAPA003896 OPENED TO INVESTIGATE THIS ISSUE FURTHER. STATUS OF THIS CAPA CURRENTLY AT IMPLEMENT ACTIONS.

    Additional Manufacturer Narrative · 0

    MANUFACTURER NARRATIVE - INITIAL INVESTIGATION COMPLETED BY THE MANUFACTURER: WORK ORDER 121568 WAS REVIEWED. NO REWORK OR SORT PERFORMED ON THIS LOT. NO NCR'S RELATED TO THIS LOT. ACCEPTED RUN AT RISK 184- RELATED TO SUCCESSFUL COMPLETION OF REFURBISHMENT OF THE MILLIPORE SYSTEM. COMPLETED AND APPROVED PRODUCTION RESTART FORM DOC-011369 REV A PRESENT IN RELATION TO FULL COOLANT CHANGE AND WASH BOWLS. IN PROCESS TESTING AND INSPECTIONS RECORDED ON DOC-011247 REV G WERE REVIEWED. THE HUB TO COVER RETENTION TEST READINGS WERE RANGING BETWEEN 1.905KGF - 7.550KGF. (SPEC MINIMUM 1.2 KGF) - PASS. THE FOLLOWING TEST WAS CARRIED OUT ON A QTY OF 18 NEEDLES (RETAINS): A HUB TO COVER RETENTION TEST - RESULTS WERE WITHIN SPECIFICATION RANGING BETWEEN 1.655KGF - 4.990KGF. (SPEC MINIMUM 1.2 KGF) - PASS. CUSTOMER HAS RETURNED DEFECT NEEDLE AND CABLE. THESE ARE CURRENTLY UNDER INVESTIGATION. 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). THE OVERALL RISK RATING IS 3A (LOW - GREEN AREA) (SEVERITY OF HAZARD - 3 - MODERATE, PROBABLILITY OF HAZARD - A - UNLIKELY). CORRECTED DATA: ON INITIAL REPORT RATIONALE WAS NOT PROVIDED FOR MISSING INFORMATION. RATIONALE INCLUDED BELOW FOR MISSING INFORMATION. A. PATIENT INFORMATION: AGE AT TIME OF EVENT, AND WEIGHT WAS REQUESTED AND THIS INFORMATION WAS NOT PROVIDED BY THE CUSTOMER. WE ARE INFORMED THAT TO QUERY ETHNICITY AND RACE UNDER FRENCH LAW IS NOT PERMITTED. B.7 OTHER RELEVANT HISTORY - REQUESTED FROM THE CUSTOMER BUT INFORMATION NOT PROVIDED. C: SUSPECT PRODUCTS - NOT APPLICABLE D4: SERIAL # - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE DOES NOT HAVE A SERIAL NUMBER. D.6: IF IMPLANTED DATE (MM/DD/YYYY) - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IMPLANTABLE. D.7 IF EXPLANTED DATE (MM/DD/YYYY) - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IMPLANTABLE. D.9 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. D.11 CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES (EXCLUDING TREATMENT OF EVENT) - THIS SECTION IS NOT APPLICABLE TO THIS TYPE OF DEVICE F: FOR USE BY USER FACILITY / IMPORTER - NOT APPLICABLE AS WE ARE NOT A FACILITY OR IMPORTER OF DEVICE. G.6 IF ND, GIVE PROTOCOL # - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IND. G.8 ADVERSE EVENT TERMS - THIS SECTION IS NOT APPLICABLE TO MEDICAL DEVICES. H.7 IF REMEDIAL ACTION INITIATED , CHECK TYPE - THIS SECTION IS NOT APPLICABLE AS NO REMEDIAL ACTION WAS INITIATED. H.9 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).

    Additional Manufacturer Narrative · 1

    WORK ORDER HAS BEEN OBTAINED AND WILL BE REVIEWED. DEFECT PARTS HAVE BEEN REQUESTED TO BE RETURNED. CUSTOMER INFORMED NATUS THAT THEY WILL BE RETURNING 11 BOXES OF NEEDLES OF THE SAME LOT NUMBER AND THE CABLE USED. IT IS UNKNOWN IF THE DEFECT NEEDLE IS BEING RETURNED FROM THE CUSTOMER AT THIS TIME.

    Description of Event or Problem · 1

    HUB SEPARATION OCCURRED; RESULTED IN A NEEDLE STICK TO THE DOCTOR. FAULTY PRODUCT: (B)(4) LOT 25B/18/D NEEDLE ISSUE. DEFECT NEEDLE, AFTER THE PLASTIC BODY WAS SEPARATED FORM THE NEEDLE, THE NEEDLE BIT PRICK WAS ALONE AT THE END OF THE CABLE EMG. THE DOCTOR STUNG HIMSELF BY REMOVING THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    985390 DANTEC CONCENTRIC NEEDLE ELECTRODE DANTEC DISPOSABLE CONCENTRIC NEEDLE IKT NATUS MANUFACTURING LTD. 9013S0012 25B/18/D

    Patients

    Seq Age Sex Outcome Treatment
    1 Congenital Anomaly| O