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

Model Number	902-DMF25-S
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Part 902-dmf25-s lot# g2009g04 hub pulling off needle when removing from patient.The affected needles are requested to be returned to gort for investigation.
Event or Problem Description
Hub is pulling off the needle when removing from patient.

• 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
• Manufacturer (Section G): NATUS MANUFACTURING LIMITED; ida business park; gort; galway, h91pd92, ; EI
• Manufacturer Contact: gráinne walsh ; ida business park; gort; galway, h91pd92, ; EI
• MDR Report Key: 11220385
• Report Number: 3005581270-2021-00001
• Device Sequence Number: 19619984
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/20/2021

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
• Device Expiration Date: 09/30/2023
• Device Model Number: 902-DMF25-S
• Device Catalogue Number: 902-DMF25-S
• Device Lot Number: G2009G04
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 01/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/30/2020
• 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 Sex: Unknown