MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. ADJUSTABLE COAXIAL TEMNO¿ A.C.T.; BIOPSY NEEDLE

Model Number	10884450444068
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During procedural equipment preparation the tip of the stylet on merit medical co-axial biopsy needle was found to be bent on 3/3 needles, two different lot #'s.Lip switched to bard product.No harm or delay to patient.

• Brand Name: ADJUSTABLE COAXIAL TEMNO¿ A.C.T.
• Common Device Name: BIOPSY NEEDLE
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 west merit parkway; south jordan UT 84095
• MDR Report Key: 12778605
• Report Number: 12778605
• Device Sequence Number: 5748982
• Product Code: FCG
• UDI-Device Identifier: 10884450444068
• UDI-Public: (01)10884450444068
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/08/2021
• Report Date (Section F): 10/08/2021

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 Model Number: 10884450444068
• Device Catalogue Number: ACT2015/B
• Device Lot Number: 12102693
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/09/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Date Report Sent to FDA: 10/08/2021