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

Model Number	9013S0032
Medical Device Problem Codes	Detachment Of Device Component (1104); Material Separation (1562)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	03/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturers initial investigation: work order (b)(4) for lot 50c/17/d was reviewed.No rework or sort performed on this lot.No excessive scrap quantities noted.No ncr's related to this lot.In process testing and inspections recorded on (b)(4) were reviewed.All samples taken for tests gave acceptable results.The results for the hub to cover retention test were within specification which is minimun 1.2kgf.Lowest value recorded was 1.700kgf, highest recorded value was 6.620kgf.The following test was carried out on a quantity of 10 needles (retains): hub to cover retention test as per (b)(4) - all needles passed with the results within minimum specifications of 1.2kgf.Lowest value recorded was 1.990kgf, highest recorded value was 4.435kgf.Defective medical device has been returned to natus manufacturing ltd.Justification for not providing below information and applicable sections: part a: patient information - no patient injury reported, device malfunction occurred.
Event or Problem Description
Hub and cannula separation from the colour cover.When pulling out the emg needle from the cable, the colour cover of the needle detached resulting in uncontrollable needle movement and risk of injury to users.
Additional Manufacturer Narrative
Visual inspection completed, complaint confirmed.Plastic colour cover separate from needle and metal hub.Cavity number of the colour cover is 4a.No further testing can be conducted as needle is disassembled.Risk assessment was completed.It was concluded that risk was categorised as low, rating 3a.There was no new hazards or no increase in probability of current hazard.No fca assessment required.(b)(4) has been opened to investigate this issue further.
Additional Manufacturer Narrative
(b)(4) is at root cause investigation and an investigation plan is in process.
Additional Manufacturer Narrative
The complaint log was reviewed for the past 12 months.4 other similar complaints have been noted for this product line, 1 similar complaint for part 9013s0032 and 3 similar complaints for part 9013s0012.Capa (b)(4) has been opened to investigate this issue further.

• Brand Name: DANTEC CONCENTRIC NEEDLE ELECTRODE
• Common Device Name: DANTEC DISPOSABLE CONCENTRIC NEEDLE
• Manufacturer (Section D): NATUS MANUFACTURING LIMITED; ida business park; gort; galway, connaught H91PD 92; EI H91PD92
• MDR Report Key: 7432641
• Report Number: 3005581270-2018-00002
• Device Sequence Number: 1094404
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/12/2018

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 12/15/2020
• Device Model Number: 9013S0032
• Device Catalogue Number: 9013S0032
• Device Lot Number: 50C/17/D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/21/2018
• Supplement Date Received by Manufacturer: 03/21/2018; 03/21/2018; 03/21/2018
• Initial Report FDA Received Date: 04/16/2018
• Supplement Report FDA Received Date: 05/15/2018; 06/13/2018; 07/12/2018
• 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