MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS MEXICO TEMNO; BIOPSY NEEDLE KIT

Model Number	T1815
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that during an interventional radiology procedure, a liver biopsy, after inserting the needle, the upper plastic part has become detached.The procedure was completed with no adverse events and the tissue samples were able to be collected.
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.The complaint is confirmed.The root cause could not be determined however, it is likely that significant force was applied to the device during clinical use.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.

• Brand Name: TEMNO
• Common Device Name: BIOPSY NEEDLE KIT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego CA 92154
• MDR Report Key: 11631529
• Report Number: 3011642792-2021-00004
• Device Sequence Number: 3658110
• Product Code: FCG
• UDI-Device Identifier: 10885403090370
• UDI-Public: 10885403090370
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K902319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2021

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 Model Number: T1815
• Device Catalogue Number: T1815
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2021
• Initial Date Received by Manufacturer: 03/26/2021
• Supplement Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 04/07/2021
• Supplement Report FDA Received Date: 06/09/2021
• 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: Required Intervention