MAUDE Adverse Event Report: CAREFUSION TEMNO BIOPSY; NEEDLE BIOPSY DEVICE

Model Number ACT 2015 20G X 15 CM

Device Problems Device Operates Differently Than Expected (2913); Mechanical Jam (2983)

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

Event Date 04/20/2017

Event Type  malfunction  

Event Description

Lung biopsy needle jammed after 4 samples were taken - on fifth sample, needle would not work properly.Device was removed from pt.

• Brand Name: TEMNO BIOPSY
• Type of Device: NEEDLE BIOPSY DEVICE
• Manufacturer (Section D): CAREFUSION; vernon hills IL 60061
• MDR Report Key: 6753659
• MDR Text Key: 81497427
• Report Number: MW5071286
• 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: 07/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/18/2021
• Device Model Number: ACT 2015 20G X 15 CM
• Device Catalogue Number: ACT2015
• Device Lot Number: 0001038751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2017
• 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
• Patient Age: 68 YR
• Patient Weight: 71