MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR INC BARD TRUGUIDE; DISPOSABLE COAXIAL BIOPSY NEEDLE

Catalog Number C@) 16A

Device Problems Difficult to Insert (1316); Material Twisted/Bent (2981)

Patient Problem Pain (1994)

Event Date 08/28/2018

Event Type  malfunction  

Event Description

While attempting to perform a liver biopsy under ct guidance, the pt complained of pain, radiologist attempted to inject add'l lidocaine through the device, there was an obstruction, so the radiologist attempted to insert stylet to advance needle but stylet would not properly insert into device.The radiologist instructed staff to obtain a ct image and at that time, it was discovered that the device had a 90 degree bend near the end of the needle.The device was removed without incident or injury to the pt.Attempt to obtain a liver sample was discontinued and biopsy rescheduled for a future date.(b)(4) at bard contacted (b)(4) 2018 (b)(4) and he will send a bio-hazard container to (b)(6) mgr to send the device back to the mfr.

• Brand Name: BARD TRUGUIDE
• Type of Device: DISPOSABLE COAXIAL BIOPSY NEEDLE
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR INC; tempe AZ
• MDR Report Key: 7865375
• MDR Text Key: 120299831
• Report Number: 7865375
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: C@) 16A
• Device Lot Number: REBW1669
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/28/2018
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/29/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 83