MAUDE Adverse Event Report: NATUS MANUFACTURING LIMITED TECA ELITE DISPOSABLE MONOPOLAR NEEDLES

Model Number	902-DMF25-S
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial report: (ref complaint# (b)(4)).Part number 902-dmf25-s, lot# g2101g01 needles pulled away from the hub.Needles requested to be returned for evaluation.
Event or Problem Description
Needles pulled away from the hub.No patient injury.
Additional Manufacturer Narrative
Follow up report 001 (ref complaint# (b)(4)).Questionnaire was sent to the customer - waiting on customer's response.The associated cable has been requested back from the customer.There are no capa's related to this issue and no complaint trends have been identified.Per qms-004442 (corporate trending and analysis procedure) complaint histories are reviewed routinely per quality system requirements and any complaint trends are assessed and documented as part of these reviews.A complaint review has been completed for the last 12 months there are no other needle hub separation complaints bar the two events that are linked to the above sr number.A review of the associated risk document ((b)(4) rev.08 - risk analysis spreadsheet for teca monopolar elite needle electrodes) was carried out with risk id (b)(4) (cannula & pin assembly separates from outer colour cover) being identified as appropriate in this case.This risk has an assigned severity of 11, therefore risk rating is critical.However, there has been no patient injury in this case.A 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.There has been no patient injury in this case.
Event or Problem Description
Needles pulled away from the hub.No patient injury.
Event or Problem Description
Needles pulled away from the hub.No patient injury.
Additional Manufacturer Narrative
Follow up report 002 (ref complaint# (b)(4)).No customer returns received into gort.If returns are recieved, the complaint will be re-open to add the investigation details.There are no capa's related to this issue and no complaint trends have been identified.Per qms-004442 (corporate trending and analysis procedure) complaint histories are reviewed routinely per quality system requirements and any complaint trends are assessed and documented as part of these reviews.A complaint review has been completed for the last 12 months there are no other needle hub separation complaints bar the two events that are linked to the above sr number.A review of the associated risk document (doc-028320 rev.08 - risk analysis spreadsheet for teca monopolar elite needle electrodes) was carried out with risk id 6.8 (cannula & pin assembly separates from outer colour cover) being identified as appropriate in this case.This risk has an assigned severity of 11, therefore risk rating is critical.However, there has been no patient injury in this case.A 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.There has been no patient injury in this case.A device history record review was completed and no issues have been noted on wo226197 dhr review was completed.No issues were highlighted during the manufacture of the needle lot, no ncr's raised against the work order or any significant scrap issues reported.Therefore, a manufacturing defect with the needle lot/batch is unlikely.Service history review: this needles is a one time use device so there is no service history on this item.Faillure confirmed:no investigation result code : neuro sbu|hub separation closure rationale: complaint verified, being tracked as a trend.

• Brand Name: TECA ELITE DISPOSABLE MONOPOLAR NEEDLES
• Common Device Name: TECA ELITE DISPOSABLE MONOPOLAR NEEDLES
• Manufacturer (Section D): NATUS MANUFACTURING LIMITED; ida business park; gort; galway h91pd92, ; EI
• MDR Report Key: 11387044
• Report Number: 3005581270-2021-00003
• Device Sequence Number: 3483823
• Product Code: IKT
• UDI-Device Identifier: 00382830017534
• UDI-Public: 00382830017534
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K111131
• 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): 02/25/2021

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: 01/31/2024
• Device Model Number: 902-DMF25-S
• Device Catalogue Number: 902-DMF25-S
• Device Lot Number: G2101G01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/25/2021
• Supplement Date Received by Manufacturer: 02/25/2021; 02/25/2021
• Initial Report FDA Received Date: 02/26/2021
• Supplement Report FDA Received Date: 03/26/2021; 05/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1