MAUDE Adverse Event Report: NATUS MANUFACTURING LIMITED TECA MYOJECT LUER LOCK NEEDLE ELECTRODE

Model Number	MJT-3726-LL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial report ref natus complaint # (b)(4).Botox was being administered by physician, with emg guidance into right mid-calf.Upon removal of injection needle, physician noted there was not a needle attached and it was in the patient's body.Physician and rn unable to palpate needle under skin.Physician called ir, patient transferred per wheelchair by medical assistant to ir.Patient informed of events with help of interpreter on wheel, id number (b)(6).(b)(6).2021: questionnaire has been sent and returns have been requested.Related device history record - (b)(4) has been requested for review.
Event or Problem Description
Botox was being administered by physician with emg guidance into right mid-calf.Upon removal of injection needle, physician noted there was not a needle attached and it was in the patient's body.
Additional Manufacturer Narrative
Follow up report 002 (ref natus complaint # (b)(4)).No product was returned for evaluation.A review of the risk document, (doc-035407 rev f ) has been completed and risk identified as6.3 (needles are thin and flexible, needle may break.) with a severity of 11 assigned.Risk therefore is determined as moderate.A further risk review is not required as this complaint does not describe a new failure mode or new harm and the existing hazard severity and/or probability of occurrence has not changed a review of the device history record (dhr) wo226203 was completed for the manufacturing lot 0846384620 with no issues noted.There were no ncrs raised in respect of the work order.There were also no scrap issues to note during production of this lot.Based on the available information a manufacturing defect is unlikely.As per qms-004442 (corporate trending and analysis procedure, rev.D), complaint histories are reviewed routinely per quality system requirements and any complaint trends are assessed and documented as part of these reviews.A review of the complaint trending completed as part of the quarterly corporate data analysis in q1, 2020 and also as part of the gort monthly complaints trending was carried out.A search for service data that may have been relevant to this issue was conducted.No further information related to this issue was found.Faillure confirmed :no investigation result code: neuro sbu|needle break closure rationale: complaint could not be verified, materials not returned for analysis.
Event or Problem Description
Botox was being administered by physician with emg guidance into right mid-calf.Upon removal of injection needle, physician noted there was not a needle attached and it was in the patient's body.
Additional Manufacturer Narrative
Follow up report 001 report (ref natus complaint # (b)(4)).The defective needles have been requested back from the customer, return label was generated however the customer has not returned the product under the returns label sent to them.There is currently no product to review or investigate.Capa and complaint trending review: as per qms-004442 (corporate trending and analysis procedure, rev.C), complaint histories are reviewed routinely per quality system requirements and any complaint trends are assessed and documented as part of these reviews.A review of the complaint trending completed as part of the quarterly corporate data analysis in q3, 2020 (ref: (b)(4) rev.D) and also as part of the (b)(6) monthly complaints trending (ref: (b)(4) rev.B) was carried out.
Event or Problem Description
Botox was being administered by physician with emg guidance into right mid-calf.Upon removal of injection needle, physician noted there was not a needle attached and it was in the patient's body.

• Brand Name: TECA MYOJECT LUER LOCK NEEDLE ELECTRODE
• Common Device Name: TECA MYOJECT LUER LOCK NEEDLE ELECTRODE
• Manufacturer (Section D): NATUS MANUFACTURING LIMITED; ida business park; gort; galway, h91 pd92, ; EI
• MDR Report Key: 11588368
• Report Number: 3005581270-2021-00005
• Device Sequence Number: 11583133
• Product Code: IKT
• UDI-Device Identifier: 00382830017725
• UDI-Public: 00382830017725
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K161430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/01/2023
• Device Model Number: MJT-3726-LL
• Device Catalogue Number: MJT-3726-LL
• Device Lot Number: 0846384620
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/29/2021
• Supplement Date Received by Manufacturer: 03/29/2021; 03/29/2021
• Initial Report FDA Received Date: 03/30/2021
• Supplement Report FDA Received Date: 04/28/2021; 05/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1