MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. TRUGUIDE; BIOPSY NEEDLE

Model Number	C1820B
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/04/2018
Type of Reportable Event	Malfunction
Event or Problem Description
At termination of an ultrasound guided liver biopsy procedure and removal of coaxial needle, the distal tip of the outer coaxial cannula appeared to be truncated.Therefore there was concern for a retained fragment.

• Brand Name: TRUGUIDE
• Common Device Name: BIOPSY NEEDLE
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 west 3rd street; tempe AZ 85281
• MDR Report Key: 7552842
• Report Number: 7552842
• Device Sequence Number: 11062988
• Product Code: FCG
• UDI-Device Identifier: 00801741085062
• UDI-Public: (01)00801741085062
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/16/2018
• Report Date (Section F): 05/16/2018

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: Physician
• Device Model Number: C1820B
• Device Catalogue Number: C1820B
• Device Lot Number: RECQ0336
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/16/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 106
• Date Report Sent to FDA: 05/16/2018