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

Model Number C1820B

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/04/2018

Event Type  malfunction  

Event 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
• Type of Device: BIOPSY NEEDLE
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 west 3rd street; tempe AZ 85281
• MDR Report Key: 7552842
• MDR Text Key: 109531761
• Report Number: 7552842
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00801741085062
• UDI-Public: (01)00801741085062
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Report Sent to FDA: 05/16/2018
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 106