MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. TEMNO®; SOFT-TISSUE BIOPSY PROCEDURE KIT

Catalog Number	CT1815/B
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
Type of Reportable Event	Malfunction
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 the needle will not pass through to coaxial.No patient injury.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.During testing, resistance was felt when inserting the biopsy needle into the coaxial.A foreign material was found on the biopsy needle.After removing the material, the needle was able to enter the full coaxial length with no issues.It cannot be determined when or how the material was introduced.The root cause remains unknown.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.Nonconformances of this nature are monitored by the operation team.This complaint will be used to trend for similar complaints.

• Brand Name: TEMNO®
• Common Device Name: SOFT-TISSUE BIOPSY PROCEDURE KIT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; calle, sor juana ines de la cr; roberto de la madrid; tijuana, b.c. 22630 ; MX 22630
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; calle, sor juana ines de la cr; roberto de la madrid; tijuana, b.c. 22630 ; MX 22630
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095 ; 8012084225
• MDR Report Key: 24119214
• Report Number: 1721504-2026-00826
• Device Sequence Number: 21232185
• Product Code: KNW
• UDI-Device Identifier: 00884450444184
• UDI-Public: 00884450444184
• Combination Product (Y/N): Y
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2026

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 Catalogue Number: CT1815/B
• Device Lot Number: I3270985
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2026
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown