MAUDE Adverse Event Report: VERAN MEDICAL TECHNOLOGIES, INC. ALWAYS-ON TIP TRACKED 22GA ANSO FLEXIBLE NEEDLE; BIOPSY NEEDLE

Model Number	INS-5410
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned for evaluation.It was confirmed the stylet was broke.A root cause for the reported failure could not be determined.Veran will continue to monitor field performance for this device.This event is being reported as a corrective action following a retrospective review of complaints in response to an observation from an external inspection.
Event or Problem Description
A veran representative was on-site when the following event occurred.When attempting to unclog the 22ga needle (ins-5410 always-on tip tracked 22ga anso flexible needle) using a stylet (ins-5411 0.016" stylet, 1235mm l), the stylet broke off leaving half the stylet still in the channel of the needle, making the 22ga needle ineffective for further use.A new 22ga needle was opened to proceed.The procedure was completed with no delay.There was no injury to the patient or user as a result of the reported issue.This report is being submitted for the 22ga needle (ins-5410).The stylet (ins-5411) is being reported on medwatch 3007222345-2023-00070.

• Brand Name: ALWAYS-ON TIP TRACKED 22GA ANSO FLEXIBLE NEEDLE
• Common Device Name: BIOPSY NEEDLE
• Manufacturer (Section D): VERAN MEDICAL TECHNOLOGIES, INC.; 1938 innerbelt business center; saint louis MO 63114
• Manufacturer (Section G): VERAN MEDICAL TECHNOLOGIES, INC.; 1938 innerbelt business center; saint louis MO 63114
• Manufacturer Contact: jennifer andre ; 1938 innerbelt business center; saint louis, MO 63114 ; 3146598500
• MDR Report Key: 17243403
• Report Number: 3007222345-2023-00071
• Device Sequence Number: 6840899
• Product Code: JAK
• UDI-Device Identifier: 00815686020637
• UDI-Public: 00815686020637
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K170023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/30/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/02/2023
• Device Model Number: INS-5410
• Device Catalogue Number: INS-5410
• Device Lot Number: 04593200625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2021
• Initial Report FDA Received Date: 06/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2020
• 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