MAUDE Adverse Event Report: NATUS MANUFACTURING LTD TECA ELITE NEEDLE; TECA ELITE DISPOSABLE CONCENTRIC NEEDLE ELECTRODE,,

Model Number	S53156
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	09/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer has reported 3 cases.On initial report it was not known if the 3 cases were of the same part number and lot number, or if the needles were used on the same patient or 3 different patients.This information was clarified by the customer on the (b)(6) 2018.The 3 incidents involved the part number s53156 and lot number 45b/17/t.This occurred after use on 3 different patients.The three incidents will be investigated under complaints and adverse event numbers: (b)(4) (ae no.3005581270-2018-00017); (b)(4) (ae no.3005581270-2018-00018); (b)(4) ((ae no.3005581270-2018-00019).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.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 no remedial action was initiated.There was no action reported under 21usc 360i(f).
Event or Problem Description
Hub separation needle issue.Defective needles, the plastic protector is released when the cable is disconnected and the needle remains connected to the needle holder.Customer has reported 3 cases.
Additional Manufacturer Narrative
Customer confirmed no patient injury occurred.Defective needles were returned to middleton however the defective product was not returned to gort from middleton.Email has been sent to the middleton qa manager to make them aware of the situation, due to the defective needles not returning to gort natus was unable to complete a full investigation on the parts.
Additional Manufacturer Narrative
Work order (b)(4) was reviewed.No ncr or rework noted.Approved production restart form (b)(4) present in relation to the grinder - full coolant change.Approved run at risk 179 and 180 related to - retest of environmental monitoring carried out in the cleanroom and the refurbishment of the millipore system.All samples taken for assembly in process tests gave acceptable results and were recorded on (b)(4).Readings for hub to cover retention test were within the minimum spec of 1.2kgf ranging between 2.460kgf - 7.020kgf.The following test was carried out on a qty of 10 needles (retains): hub to cover retention test as per (b)(4) - all needles passed with results within minimum spec of 1.2kgf.Lowest value recorded was 2.610kgf, highest recorded value was 6.9200kgf.(b)(4) risk and risk management report - teca disposable needles and value disposable needles and value line dcn was reviewed.There are two potential hazards and hazardous situations associated with physical injury - needle stick, id 25 (needles are sharp, users could pierce themselves) and 31 (cannula & hub assembly separates from outer color cover).The overall risk rating is 3a (severity of hazard - 3- moderate, probability of hazard - a - unlikely).Capa004168 has been opened to investigate this issue.

• Brand Name: TECA ELITE NEEDLE
• Common Device Name: TECA ELITE DISPOSABLE CONCENTRIC NEEDLE ELECTRODE,,
• Manufacturer (Section D): NATUS MANUFACTURING LTD; ida business park; gort; galway, connaught H91PD 92; EI H91PD92
• MDR Report Key: 8173502
• Report Number: 3005581270-2018-00018
• Device Sequence Number: 13988848
• Product Code: IKT
• UDI-Device Identifier: 00382830017503
• UDI-Public: 00382830017503
• Combination Product (Y/N): N
• PMA/510(K) Number: K112034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/07/2019

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: 11/07/2020
• Device Model Number: S53156
• Device Catalogue Number: S53156
• Device Lot Number: 45B/17/T
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/09/2018
• Supplement Date Received by Manufacturer: 11/09/2018; 11/09/2018
• Initial Report FDA Received Date: 12/18/2018
• Supplement Report FDA Received Date: 01/14/2019; 02/07/2019
• 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