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

Model Number	9013S0032
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	07/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device history record to be reviewed.Defective part requested to be returned.Further information requested from the customer.Patient information - no patient injury reported, device malfunction occurred.Other relevant history, including preexisting medical conditions: this section is not applicable as no patient injury occurred.Suspect products - not applicable.Serial # the medical device does not have a serial number.The medical device is not implantable.The medical device is not a single-use device that was reprocessed or reused on a patient.
Event or Problem Description
Hub and cannula separation from colour cover during removal of connector cable."when pulling out the emg needle, the plastic socket will detach at the connection of emg needle to lead cable, thereby uncontrollable needle movement and risk of injury to users.".
Additional Manufacturer Narrative
Work order (b)(4) was reviewed.No rework or sort performed on this lot.No ncr's noted.In process testing and inspections recorded on doc-011247 rev f were reviewed.All samples taken for tests gave pass results.2 x production restart forms doc-011369 rev a were present in relation to the sortimat grippers adjustment and grinder full coolant change.All tests were carried out for production to restart and both were approved by engineering.1 used needle was returned for investigation.A visual inspection was completed, the complaint is confirmed.Plastic colour cover separated from needle and metal hub.Cavity number of the colour cover is 4a.No further testing can be conducted as needle is disassembled.Doc-010782 risk management report for dantec dcn was reviewed.Potential hazard and hazardous situation identified associated with physical injury - needle stick, id 23 (needles are sharp, users could pierce themselves) and physical injury - cannula & hub assembly separated from outer colour cover, id 29 (users could pierce themselves).The overall risk rating is 3a (low - green area) (severity of hazard - 3 - moderate, probability of hazard - a-unlikely).The complaint log was reviewed over 12 months, 6 similar complaints noted for this product line.Capa003896 has been opened to investigate 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: 7784042
• Report Number: 3005581270-2018-00007
• Device Sequence Number: 192172
• Product Code: IKT
• UDI-Device Identifier: 05704736002875
• UDI-Public: 05704736002875
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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
• Report Date (Section B): 09/13/2018

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: 07/05/2020
• Device Model Number: 9013S0032
• Device Catalogue Number: 9013S0032
• Device Lot Number: 27B/17/D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2018
• Initial Date Received by Manufacturer: 07/16/2018
• Supplement Date Received by Manufacturer: 07/16/2018
• Initial Report FDA Received Date: 08/15/2018
• Supplement Report FDA Received Date: 09/13/2018
• 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