MAUDE Adverse Event Report: CAREFUSION 2200, INC TEMNO EVOLUTION; BIOPSY NEEDLE

Catalog Number CTT1411

Device Problem Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/31/2022

Event Type  malfunction  

Event Description

The introducer/coaxial needle will not separate from the outer needle.Another temno had to be opened to use for the procedure.

• Brand Name: TEMNO EVOLUTION
• Type of Device: BIOPSY NEEDLE
• Manufacturer (Section D): CAREFUSION 2200, INC; 75 north fairway drive; vernon hills IL 60061
• MDR Report Key: 14135007
• MDR Text Key: 289447539
• Report Number: 14135007
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/03/2022

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 Catalogue Number: CTT1411
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/03/2022
• Event Location: Hospital
• Date Report to Manufacturer: 04/18/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/18/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 16790 DA
• Patient Sex: Female
• Patient Weight: 113 KG
• Patient Race: White