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

Model Number JBC1213

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/23/2017

Event Type  No Answer Provided  

Event Description

While removing a bone biopsy needle from the sacrum, the hub detached from the needle while still in the pt.Able to remove the aid of a surgical forceps.No negative effect to the pt and was able to obtain an adequate sample.Pt made aware that no add'l samples could be obtained due to the needle failure (avamax coaxia bone biopsy needle 13 g; ref number jbc1213, lot 0000998397 exp date: 08/31/2018.).

• Brand Name: AVAMAX ADVANCED VERTEBRAL AUGMENTATION
• Type of Device: BONE BIOPSY NEEDLE
• Manufacturer (Section D): CAREFUSION; vernon hills
• MDR Report Key: 6680409
• MDR Text Key: 78996472
• Report Number: MW5070726
• 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: Nurse
• Type of Report: Initial
• Report Date: 06/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Model Number: JBC1213
• Device Lot Number: 0000998397
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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