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	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The physician reported that after sampling, the ins-5410 (always-on tip tracked 22ga anso flexible needle, 15mm l, 1.8mm od) would not retract back into the sheath of the instrument.The intended procedure was able to be completed with no delay.There was no patient or user injury reported due to this issue.
Additional Manufacturer Narrative
The device was not returned for evaluation.Based on the results of the investigation, the inability of the needle to retract back into the sheath can be attributed to several different mechanical root causes.These include improper assembly of the ins-5410 flexible needle, subcomponents within the ins-5410 flexible needle were out of specification (i.E., incorrect dimensions), or subcomponent failure within the ins-5410 flexible needle causing blockages and inability to retract back into the sheath; however, a definitive root cause could not be determined, since the device was not returned.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.

• 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
• MDR Report Key: 17221627
• Report Number: 3007222345-2023-00039
• Device Sequence Number: 20386927
• Product Code: JAK
• UDI-Device Identifier: 00815686020637
• UDI-Public: 00815686020637
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 06/28/2023

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: 06/23/2023
• Device Model Number: INS-5410
• Device Catalogue Number: INS-5410
• Device Lot Number: 04593200615
• 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: 07/21/2021
• Initial Report FDA Received Date: 06/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2020
• 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