MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. BARD® MISSION®; INSTRUMENT, BIOPSY

Model Number	2016MSK
Health Effect - Clinical Codes	Needle Stick/Puncture (2462); Foreign Body In Patient (2687)
Date of Event	02/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During an ir procedure for biopsy of a lung lesion, the patient coughed, and this resulted in the bending of the 19 g outer cannula at an acute angle.Gentle traction was applied resulting in the fracture of the needle.While attempting to remove the needle, the device fractured further resulting in a 4cm fragment protruding into the intercostal muscles, traversing the pleural space and then entering the lower lobe.

• Brand Name: BARD® MISSION®
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w. 3rd st.; tempe AZ 85281
• MDR Report Key: 16627056
• Report Number: 16627056
• Device Sequence Number: 4517019
• Product Code: KNW
• UDI-Device Identifier: 00801741097096
• UDI-Public: (01)00801741097096
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/15/2023
• Report Date (Section F): 03/15/2023

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 Model Number: 2016MSK
• Device Catalogue Number: 2016MSK
• Device Lot Number: 0001492476
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 03/28/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/28/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other; Hospitalization
• Patient Sex: Female
• Patient Weight: 88 KG
• Patient Race: White
• Date Report Sent to FDA: 03/15/2023