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

Model Number INS-5410

Device Problems Break (1069); Insufficient Information (3190)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/17/2021

Event Type  malfunction  

Event Description

22ga needle broke while the doctor was using it in the scope inside the patient.The doctor saw the error message and made sure to carefully remove the broken device.

Manufacturer Narrative

This report is being supplemented to correct information provided in the initial medwatch report, to provide additional information that was inadvertently not provided in the initial report, and to provide details regarding the investigation.Correction to b4 of the initial report: date of this report was 16-jul-2021.Correction to g3 of the initial report: date received by manufacturer was 17-jun-2021.The subject device was returned for investigation more than 60 days after the return authorization was issued.However, the device was accidentally scrapped before the device could be evaluated.The investigation determined that the system specifications for the device have a tensile force requirement.The device passed verification testing.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.

Event Description

Additional information regarding the reported event: after the device was removed from the patient, they visualized the device snapped at the more proximal end, which was approximately 2-3cm from the end of the needle.There was no harm or injury to the patient or user of the device.There was a minor delay when opening a 19ga needle to proceed with the case.The needle was reportedly still in one piece when it was removed from the patient.

• 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: 12186013
• MDR Text Key: 264791181
• Report Number: 3007222345-2021-00014
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 00815686020637
• UDI-Public: 00815686020637
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/04/2022
• Device Model Number: INS-5410
• Device Catalogue Number: INS-5410
• Device Lot Number: 04118191016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/10/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1