MAUDE Adverse Event Report: CAREFUSION TEMNO; ACT TEMNO 18 G X 20 CM

Model Number ACT1820

Device Problem Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/08/2014

Event Type  malfunction  

Event Description

A (b)(6) male with lymphoma under going ct guided mesenteric biopsy.Doctor tested the trocar prior to use and felt resistance of the trocar.A scaping type could be heard.He did not use the device on the patient.Biopsy was completed without incident.Unable to return the device to the product rep due to contaminated with body fluids.

• Brand Name: TEMNO
• Type of Device: ACT TEMNO 18 G X 20 CM
• Manufacturer (Section D): CAREFUSION; mcgaw park 60085
• MDR Report Key: 3820508
• MDR Text Key: 4504179
• Report Number: MW5036149
• 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: 05/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/17/2018
• Device Model Number: ACT1820
• Device Lot Number: 0000584293
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Weight: 104