MAUDE Adverse Event Report: VERAN MEDICAL TECHNOLOGIES, INC. ALWAYS-ON TIP TRACKED 21GA ANSO CYTOLOGY NEEDLE; BIOPSY NEEDLE

Model Number	INS0392
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned for evaluation.During the initial inspection, the device worked as intended.During testing, the engineer was able to pull the needle back behind the protective stop with excessive force.A definitive root cause of the reported issue 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
The physician reported the hub and suction adapter of the 21ga needle (ins-0392 always-on tip tracked 21ga anso cytology needle) was defective and not fully closing.A new needle was opened to complete the procedure.The procedure was able to be completed with no delay.There was no injury to the patient or user as a result of the reported issue.

• Brand Name: ALWAYS-ON TIP TRACKED 21GA ANSO CYTOLOGY 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: 17243629
• Report Number: 3007222345-2023-00074
• Device Sequence Number: 14651577
• Product Code: JAK
• UDI-Device Identifier: 00815686020613
• UDI-Public: 00815686020613
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• 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: 03/28/2023
• Device Model Number: INS0392
• Device Catalogue Number: INS-0392
• Device Lot Number: 04449200325
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2021
• Initial Report FDA Received Date: 06/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2023
• 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
• Patient Sex: Unknown