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

Catalog Number ACT2020

Device Problem Failure to Disconnect (2541)

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

Event Date 01/05/2017

Event Type  malfunction  

Event Description

Device malfunction: biopsy needle became lodged in trocar.Dr.Was unable to separate the needle from trocar.Entire system (needle+trocar) had to be removed from patient.

• Brand Name: TEMNO NEEDLE BIOPSY
• Type of Device: NEEDLE BIOPSY DEVICE
• Manufacturer (Section D): BD; vernon hills IL 60061
• MDR Report Key: 6237985
• MDR Text Key: 64591103
• Report Number: MW5067160
• 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: 01/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/21/2021
• Device Catalogue Number: ACT2020
• Device Lot Number: 000090303988
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 63