MAUDE Adverse Event Report: NATUS MANUFACTURING LIMITED TECA CONCENTRIC NEEDLES

Model Number	S53153
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Part s53153, concentric needles.The customer stated: a couple of weeks ago, we had a needle break at the hub though was able to retrieve it from the patient.
Additional Manufacturer Narrative
Initial report ref natus complaint# (b)(4).Expiration date and manufacturer date of the product to be confirmed.A questionnaire has been sent to the customer to complete and also a request for the needles to be returned for evaluation.
Event or Problem Description
Part s53153, concentric needles.The customer stated: a couple of weeks ago, we had a needle break at the hub though was able to retrieve it from the patient.
Additional Manufacturer Narrative
Follow up report 001 ref natus complaint#(b)(4).Included expiration date in section d4.Entered manufacturer date in section h4.The needle dislodged from the hub.Location was the neck muscle and the physician was able to remove the needle easily.Risk review: per doc-028319 rev 15 risk analysis spreadsheet for teca dcn electrodes hazard 6.6 - needles are thin / flexible may break.Effects (harm) worst case - cannula end breaks off inside patient and has to be surgically removed.Residual risk: moderate the affected needles to be returned to natus for evaluation.
Additional Manufacturer Narrative
Follow up report 002 ref natus complaint # (b)(4).Part s53153 lot 28a/24/t was built on work order # (b)(4).The device history record shows a total of 500 needles scrapped of 26,850 needles produced.The scrap parts were across 3 steps of the work order.1.7% failure overall.No operation step exceeded the 1% failure rate.No issues were recorded.The quantity of (b)(4) units at (operation 100- automatic assembly) are where the testing for the komax 4 assembly is performed.The hub to cannula tensile test and hub to colour cover retention show all tests passed.The device history record shows no anomalies for the complaint.No related capa.From this investigation, the device history record review did not show any anomalies for the complaint including a review of all applicable measurements.No product examination as the product was not returned.
Event or Problem Description
Part s53153, concentric needles.The customer stated: a couple of weeks ago, we had a needle break at the hub though was able to retrieve it from the patient.
Additional Manufacturer Narrative
Follow up report 003 ref natus complaint#(b)(4).The risk file (b)(4) for the teca dcn electrodes was updated to rev 16.The risk / benefit analysis for hazard 6.6 was updated as follows: the hazards identified have been reduced as far as possible, and the residual risk for these hazards is mainly associated with the needle having wrong specification/ manufacturing defect.The device is designed and manufactured to mitigate the risk of a faulty needle reaching the customer and the risk is reduced as far as possible by performing 100% inspection of the needles.The remaining risk associated with the use of the product is outweighed by the benefit of its intended use.
Event or Problem Description
Part s53153, concentric needles.The customer stated: a couple of weeks ago, we had a needle break at the hub though was able to retrieve it from the patient.

• Brand Name: TECA CONCENTRIC NEEDLES
• Common Device Name: TECA CONCENTRIC NEEDLES
• Manufacturer (Section D): NATUS MANUFACTURING LIMITED; ida business park; gort; galway h91pd92, ; EI
• Manufacturer (Section G): NATUS MANUFACTURING LIMITED; ida business park; gort; galway, h91pd92, ; EI
• Manufacturer Contact: gráinne walsh ; ida business park; gort; galway, H91PD-92 ; EI H91PD92
• MDR Report Key: 20898342
• Report Number: 3005581270-2024-00009
• Device Sequence Number: 5052459
• Product Code: IKT
• UDI-Device Identifier: 00382830017480
• UDI-Public: 00382830017480
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K112034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/27/2025

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 Model Number: S53153
• Device Catalogue Number: S53153
• Device Lot Number: 28A/24/T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 01/09/2025; 05/06/2025; 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/08/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White