MAUDE Adverse Event Report: VERAN MEDICAL TECHNOLOGIES, INC ALWAYS-N TIP TRACKED 19GA HISTOLOGY NEEDLE; BIOPSY NEEDLE

Model Number	INS-0382
Medical Device Problem Codes	Retraction Problem (1536); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A rma was issued, however the device has not been received at the time of this report.
Event or Problem Description
During a procedure, the physician requested "needle back." the physician removed the needle, but it was noted that the needle was still extended.Attempts were made to retract the needle back into the sheath, and a nurse tried to physically force the needle back, but it was locked in the out position the scope was checked for damage and no damage was detected.The veran rep in the procedure plugged the needle back into the system after the procedure and no additional coil break or error message was noted.Once the needle break was detected, the physician moved from a veran procedure over to an ebus procedure to complete the procedure.
Event or Problem Description
Additional information regarding the reported event: there was no injury to a patient or user as a result of the reported issue.The procedure was able to be completed after a minor delay of five (5) minutes.
Additional Manufacturer Narrative
This report is being supplemented to provide information that was inadvertently not included in the initial medwatch report.G3: date received by manufacturer was blank in the initial medwatch report and should have been 24-mar-2022.The subject device was not returned for evaluation; therefore, a root cause 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-N TIP TRACKED 19GA HISTOLOGY 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: 14190072
• Report Number: 3007222345-2022-00014
• Device Sequence Number: 14672079
• Product Code: JAK
• UDI-Device Identifier: 00815686020590
• UDI-Public: 00815686020590
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2023

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: 08/09/2022
• Device Model Number: INS-0382
• Device Catalogue Number: INS-0382
• Device Lot Number: 03954190801
• 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: 06/13/2023
• Initial Report FDA Received Date: 04/22/2022
• Supplement Report FDA Received Date: 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2019
• 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