MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. TEMNO ELITE BIOPSY NEEDLE; INSTRUMENT, BIOPSY

Catalog Number	TEVC1815
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is not expected to be returned for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The accounted alleges that during a diagnostic procedure, the device was used to successfully obtain a biopsy sample.However, while attempting to advance the sample into a specimen jar the handle of the device broke apart and the clinician suffered a needle stick injury.The clinician underwent mandatory bbp testing and the injury was cleaned per hospital protocol.A second device was used to successfully obtain and deposit a patient biopsy sample into the specimen jar without incident.No additional patient or clinician consequences to report.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed and a root cause could not be determined.A review of the complaint database was performed and no similar complaints for this lot were identified.A review of the device history record was performed and no exception documents were found.

• Brand Name: TEMNO ELITE BIOPSY NEEDLE
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 18983986
• Report Number: 1721504-2024-00021
• Device Sequence Number: 8232258
• Product Code: KNW
• UDI-Device Identifier: 00884450397725
• UDI-Public: 884450397725
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K201166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: TEVC1815
• Device Lot Number: H2821003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/11/2024
• Initial Report FDA Received Date: 03/26/2024
• Supplement Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/05/2023
• 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
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown