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

Model Number INS-5410

Device Problem Material Integrity Problem (2978)

Patient Problems Chest Pain (1776); Cough (4457)

Event Date 08/16/2021

Event Type  Injury  

Manufacturer Narrative

Note- this report was originally submitted on 10/27/2021.A previous employee, (b)(6), submitted on her account and did not realize that the report was sent back with an error.This error occurred 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 should have been 007222345-2021-017).These errors have been corrected for this report and all information contained in this report is accurate at the time of this submission on march 3, 2022.The original report and the esg submission error message reports are all included in this report as evidence that veran submitted during the 30 day window.

Event Description

Doctor notified veran representative on 9/27/2021 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 report to their physician yet.The thoracic surgeon was able to remove the needle tip on (b)(6)2021.Patient recovered and was discharged.

• Brand Name: ALWAYS-ON TIP TRACKED 22GA ANSO FLEXIBLE NEEDLE
• Type of Device: 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: 13770722
• MDR Text Key: 287249600
• Report Number: 3007222345-2021-00017
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: INS-5410
• Device Catalogue Number: INS-5410
• Date Manufacturer Received: 09/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Prefer Not To Disclose