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

Model Number	INS-5410
Health Effect - Clinical Codes	Chest Pain (1776); Foreign Body In Patient (2687); Cough (4457)
Date of Event	08/16/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Doctor notified veran representative on (b)(6) 2021 that during a procedure on (b)(6) 2021 that the tip of a 22ga needle had broken off in a patient.The surgeon and staff did not notice the broken needle at the time of the procedure.The procedure being performed was a lung biopsy of a lul medial mass.The surgeon stated that he did not feel anything or noticed any issues during the procedure.The patient was diagnosed with cancer from the biopsy and was referred to a thoracic surgeon to get the mass removed.The thoracic surgeon performed an x-ray and noticed the needle tip in the lung.At this time, the patient noted that they had a persistent cough and chest pain that they hadn't reported to their physician yet, the thoracic surgeon was able to remove the needle tip on (b)(6) 2021.Patient recovered and was discharged.
Additional Manufacturer Narrative
This report was originally submitted on (b)(6) 2021.A previous employee, (b)(6), submitted the report with her account and did not realize that the report was rejected with an error.This error occured due to an incorrect report number used.The report number was put in the wrong location (uf importer report # instead of mfr report #) and the report number was duplicated from a previously submitted report (3007222345-2021-0016 was submitted and it should ave been 3007222345-2021-0017).From january to march 2022, the regulatory team worked with (b)(6) at the fda medwatch program to correct these submission errors for this report.Mr.(b)(6) notified veran that all the reports with this number had been removed from the system and that it was appropriate to re-submit the original file with the 3007222345-2021-0017.However, after repeated attempts, veran has been unsuccessful in getting this report number to be accepted.Therefore, the report number has been updated to 3007222345-2021-0025.All information contained in this report is accurate at the time of this submission on april 22, 2022 and the information about the medical event that occurred has not changed since the original failed submission on october 27, 2021.The original report and the esg submission error message reports are included in this report as evidence that veran attempted to submit the medical event that occurred during the 30 day window.Also included is the correspondence with the medwatch employee.
Additional Manufacturer Narrative
This report is being supplemented to provide information that was inadvertently not included in the initial medwatch report, to provide information regarding the investigation of the event, and to correct information provided in the initial report.Correction to b1/b2: this event is considered to be both an adverse event and a product problem.G3 of the initial medwatch report was blank: date received by manufacturer was 27-sep-2021.No additional information was received regarding the procedure.The lot number was not known and the broken needle was not returned for evaluation.A photo of the broken piece was provided.According to the investigation, no similar complaints of this nature were found.The needle is designed to capture the fractured section of the needle.The root cause of the broken needle could not be determined.Veran will continue to monitor field performance for this device.This supplemental report is being submitted as a corrective action following a retrospective review of complaints in response to an observation from an external inspection.

• Brand Name: ALWAYS-ON TIP TRACKED 22GA ANSO FLEXIBLE NEEDLE
• Common Device Name: 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: 14190405
• Report Number: 3007222345-2021-00025
• Device Sequence Number: 4474345
• Product Code: JAK
• UDI-Device Identifier: 00815686020637
• UDI-Public: 00815686020637
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 08/14/2023

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: INS-5410
• Device Catalogue Number: INS-5410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/11/2022
• Initial Report FDA Received Date: 04/22/2022
• Supplement Report FDA Received Date: 08/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Prefer Not To Disclose