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

Lot Number REDS2594

Device Problems Misfire (2532); Activation, Positioning or Separation Problem (2906)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/08/2019

Event Type  malfunction  

Event Description

Pt was here for liver tx. Using a 16x16g bard biopsy device, while attempting to take specimen, the device misfired and needle did not deploy. The pa attempted to deploy needle outside of pt and the device still did not deploy; 16gx16g bard - lot # reds2594. Fda safety report id# (b)(4).

• Brand Name: BIOPSY DEVICE
• Type of Device: BIOPSY NEEDLE
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.
• MDR Report Key: 8939622
• Report Number: MW5089375
• 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: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Lot Number: REDS2594
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

• Patient Age: 45 YR