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

Model Number	INS-5410
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	10/05/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was a (b)(6) male.Physician used the forceps to register and navigate out to the target (rll).Three samples were then taken with the forceps.Three samples were also taken with the 22g needle and the aott brush.After sampling, physician finished the procedure with a bal.Afterward, a potable chest x-ray revealed the presence of a pneumothorax.A small, right-sided chest tube was placed, and the patient is in stable condition.The patient is expected to make a full recovery and was dismissed from the hospital on (b)(6) 2020.

• Brand Name: ALWAYS-ON TIP TRACKED 22GA ANSO SPIN FLEX NEEDLE
• Common Device Name: ALWAYS-ON TIP TRACKED 22GA ANSO SPIN FLEX NEEDLE
• Manufacturer (Section D): VERAN MEDICAL TECHNOLOGIES, INC; 1908 innerbelt business center; saint louis MO 63114
• MDR Report Key: 10698068
• Report Number: 3007222345-2020-00012
• Device Sequence Number: 19648045
• Product Code: JAK
• UDI-Device Identifier: 00815686020637
• UDI-Public: 00815686020637
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/19/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/16/2022
• Device Model Number: INS-5410
• Device Catalogue Number: INS-5410
• Device Lot Number: 04118191016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2020
• Initial Report FDA Received Date: 10/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 69 YR