BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BO-JECT NEEDLE ELECTRODE

    MDR report key: 8160267 · Received December 13, 2018

    Report

    Report Number
    3005581270-2018-00016
    Event Type
    Injury
    Date Received
    December 13, 2018
    Date of Event
    December 4, 2018
    Report Date
    February 7, 2019
    Manufacturer
    NATUS MANUFACTURING LIMITED
    Product Code
    IKT
    UDI-DI
    00382830042420
    PMA / PMN Number
    K161430
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEFECTIVE PRODUCT WILL NOT BE RETURNING, THE CUSTOMER HAS STATED IT IS NOT AVAILABLE. WORK ORDER (B)(4) WAS REVIEWED. NO NON-CONFORMING REPORTS RELATED TO THIS LOT. ALL RESULTS RECORDED ON LUER LOCK CRIMP IN-PROCESS INSPECTION FORM DOC-011299 REV H WERE WITHIN SPECIFICATION >22N, READINGS BETWEEN 30N - 40N. TWO DOCUMENTED ATTEMPTS HAVE BEEN MADE TO GAIN MORE INFORMATION ABOUT THE REPORTED ISSUE AND THE MISSING INFORMATION ON THE INITIAL MEDWATCH REPORT FORM, NO FURTHER INFORMATION HAS BEEN PROVIDED BY THE CUSTOMER.

    Additional Manufacturer Narrative · 0

    APPROVED CERTIFICATE OF CONFORMITY AND TEST DATA SHEETS ATTACHED IN RELATED TO THE NEEDLE BLANK 25MM X 30G PART 017Y479 LOT: 000417 (ATTACHMENT#5). TESTING OF THE RETAINS FOR THIS LOT IS NOT REQUIRED AS NO RELATED TESTS TO BE CARRIED OUT FOR THIS ISSUE. THE RISK OF THIS COMPLAINT WAS REVIEWED UNDER (B)(4) RISK MANAGEMENT REPORT FOR TECA DISPOSABLE NEEDLE AND VALUE LINE DCN AND THE RISK RATING FOUND IS LOW 3A. THE COMPLAINT LOG HAS BEEN REVIEWED OVER A PERIOD OF 12 MONTHS FOR THIS PRODUCT LINE. NO OTHER SIMILAR COMPLAINT HAS BEEN RECEIVED. NO TREND OBSERVED. RATIONALE FOR NOT PROVIDING THE FOLLOWING INFORMATION (UPDATE): A. PATIENT INFORMATION: CUSTOMER INFORMED NATUS THAT PATIENT INFORMATION IS NOT AVAILABLE FOR RELEASE. B.5 DESCRIBE EVENT OR PROBLEM: FURTHER INFORMATION ON DESCRIPTION OF EVENT RECEIVED FROM FACILITY MED WATCH FORM AND ADDED TO THIS SECTION. B6 & B7: CUSTOMER INFORMED NATUS THAT PATIENT INFORMATION IS NOT AVAILABLE FOR RELEASE. CONCOMITANT MEDICAL PRODUCTS: CUSTOMER INFORMED NATUS THAT PRODUCT WAS NOT AVAILABLE FOR RETURN.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION: DURING PROCEDURE TO INJECT BOTULINUM TOXIN IN THE RIGHT MEDIAL HAMSTRING THE NEEDLE BROKE REQUIRING SURGICAL INTERVENTION TO RETRIEVE THE NEEDLE.

    Additional Manufacturer Narrative · 1

    WORK ORDER AND NEEDLE RETAINS OF THE SAME LOT HAVE BEEN PULLED AND IS WITH QUALITY AND ENGINEERING. QUESTIONNAIRE SENT TO THE CUSTOMER REQUESTING FURTHER INFORMATION ABOUT THE EVENT AND REQUESTED THE RETURN OF THE DEFECT PRODUCT FOR EVALUATION. JUSTIFICATION FOR NOT PROVIDING BELOW INFORMATION AND APPLICABLE SECTIONS: A. PATIENT INFORMATION - PATIENT INFORMATION HAS BEEN REQUESTED FORM THE CUSTOMER, WAITING ON A RESPONSE. RELEVANT TESTS / LABORATORY DATA - THIS INFORMATION WAS REQUESTED FROM THE CUSTOMER BUT NO INFORMATION HAS YET BEEN PROVIDED. OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS - THIS INFORMATION WAS REQUESTED FROM THE CUSTOMER BUT NO INFORMATION HAS YET BEEN PROVIDED. SERIAL # - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE DOES NOT HAVE A SERIAL NUMBER. 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. HEALTH PROFESSIONAL? - THIS INFORMATION AHS BEEN REQUESTED, WAITING A RESPONSE. OCCUPATION - THIS INFORMATION AHS BEEN REQUESTED, WAITING A RESPONSE. 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

    FAULTY PART : PART # 9013S0422 AND LOT # 1803LL04. THE DOCTOR WAS USING A BOJECT DISPOSABLE HYPODERMIC NEEDLE ELECTRODE WITH THE CLAVIS. THE NEEDLE BROKE OFF WHILE IN THE PATIENT. THE (B)(6) HOSPITAL REQUEST TO RETURN 7 BOXES OF ITEM #9013S0422 HYPODERMIC ELECTRODE NEEDLE DUE TO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1002690 BO-JECT NEEDLE ELECTRODE BO-JECT DISPOSABLE HYPODERMIC NEEDLE ELECTRODES IKT NATUS MANUFACTURING LIMITED 9013S0442 1803LL04 00382830042420

    Patients

    Seq Age Sex Outcome Treatment
    1 Other