MAUDE Adverse Event Report: NATUS MANUFACTURING LIMITED DANTEC CONCENTRIC NEEDLE ELECTRODE; DANTREC DISPOSABLE CONCENTRIC NEEDLE

Model Number	9013S0032
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	02/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturers initial investigation: work order (b)(4) was reviewed.Run at risk 180 noted for retest of environmental monitoring carried out in the cleanroom.In process testing and inspections were reviewed - hub to cover retention test readings ranging between 1.215 - 6.580 kgf, hub to cannula tensile test ranging from 21.13 - 32.98 ibf.All results were acceptable and recorded on (b)(6).The following tests were completed on a qty of 7 needles (retains) as per (b)(6) rev d: hub to cover retention test: ranging between 2.560 - 4.750kgf - pass.Hub to cannula tensile test ranging between 23.77 - 30.98 ibf - pass.Customer completed the questionnaire and provided further information.Manufacturing engineer has reviewed customer response and has concluded: "colour cover separation after procedure when pulling the cable connector off the needle.Problem with colour cover too lose or connector too tight." product return requested from the customer but the customer has already disposed of the defective part.Customer has been contacted to provide the rest of the required information below but the following information has not been provided to us.Patient weight, concomitant medical products and therapy dates (excluding treatment of event), customer has confirmed that there was no other relevant data in relation to other relevant history, including pre-existing medical conditions.Justification for not providing below information and applicable sections: serial # - this section is not applicable as the medical device does not have a serial number.If implanted date (mm/dd/yyyy) - this section is not applicable as the medical device is not implantable.If explanted date (mm/dd/yyyy) - this section is not applicable as 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 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 21 usc 360i(f).
Event or Problem Description
Part number: 9013s0032 dantec concentric needle, lot: 44b/17/d - needle disengaged and the doctor was hurt.In trying to disconnect the emg needle from the cable with the thumb and index finger, the plastic of the cover assembly slipped over the solid parts of the needle cranially, thereby a stitch in the thumb occurred.
Additional Manufacturer Narrative
Work order (b)(4) was reviewed.Run at risk 180 noted for retest of environmental monitoring carried out in the cleanroom.In process testing and inspections were reviewed - hub to cover retention test readings ranging between 1.215 - 6.580 kgf, hub to cannula tensile test ranging from 21.13 - 32.98 ibf.Results: all results were acceptable and recorded on (b)(4).The following tests were completed on a qty of 7 needles (retains) as per (b)(4) rev d: hub to cover retention test: ranging between 2.560 - 4.750 kgf - results: pass.Hub to cannula tensile test ranging between 23.77 - 30.98 ibf - results: pass.Customer completed the questionnaire and provided further information.Manufacturing engineer has reviewed customer response and has concluded: results: "colour cover separation after procedure when pulling the cable connector off the needle.Problem with colour cover too lose or connector too tight." product return requested from the customer but the customer has already disposed of the defective part.Results: problem device not returned, no further investigation could be carried out.No further information obtained from the customer.Complaint closed to capa(b)(4).

• Brand Name: DANTEC CONCENTRIC NEEDLE ELECTRODE
• Common Device Name: DANTREC DISPOSABLE CONCENTRIC NEEDLE
• Manufacturer (Section D): NATUS MANUFACTURING LIMITED; ida business park; gort; galway, connaught H91PD 92; EI H91PD92
• MDR Report Key: 7345106
• Report Number: 3005581270-2018-00001
• Device Sequence Number: 16164120
• Product Code: IKT
• UDI-Device Identifier: 05704736002875
• UDI-Public: 05704736002875
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K112034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 11/01/2020
• Device Model Number: 9013S0032
• Device Catalogue Number: 9013S0032
• Device Lot Number: 44B/17/D
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/15/2018
• Supplement Date Received by Manufacturer: 02/15/2018
• Initial Report FDA Received Date: 03/16/2018
• Supplement Report FDA Received Date: 04/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 35 YR