MAUDE Adverse Event Report: CAREFUSION TENMO ACT BIOPSY KIT; BIOPSY NEEDLE

Catalog Number ACT2020

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/21/2017

Event Type  malfunction  

Event Description

A (b)(6) female found to have large lung mass requiring ct-guided needle biopsy.Tenmo needle biopsy system kept jamming during procedure.Physician was able to obtain 8 biopsy samples.No adverse effect on patient, but could have limited number of biopsy samples requiring a repeat procedure.

• Brand Name: TENMO ACT BIOPSY KIT
• Type of Device: BIOPSY NEEDLE
• Manufacturer (Section D): CAREFUSION; vernon hills IN 60061
• MDR Report Key: 6823278
• MDR Text Key: 83863232
• Report Number: MW5071806
• 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: 08/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/24/2021
• Device Catalogue Number: ACT2020
• Device Lot Number: 0000988122
• Was Device Available for Evaluation?: No
• 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: 81 YR
• Patient Weight: 81