MAUDE Adverse Event Report: CAREFUSION AVAMAX ADVANCED VERTEBRAL AUGMENTATION; BIOPSY NEEDLE

Model Number JBC1213

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 02/08/2017

Event Type  Injury  

Event Description

During a ct guided biopsy of the left l3 pedicle, the hub of an avamax bone biopsy needle (lot #000961795) became dislodged as it was grasped by hand in an attempt to remove it from the bone.No retained needle fragments in the pt.

• Brand Name: AVAMAX ADVANCED VERTEBRAL AUGMENTATION
• Type of Device: BIOPSY NEEDLE
• Manufacturer (Section D): CAREFUSION; vernon hills IL 60061
• MDR Report Key: 6328616
• MDR Text Key: 67501708
• Report Number: MW5067859
• Device Sequence Number: 1
• Product Code: FCG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/10/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Model Number: JBC1213
• Device Lot Number: 0000961795
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/10/2017
• 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 Outcome(s): Other; Required Intervention
• Patient Age: 87 YR
• Patient Weight: 73