MAUDE Adverse Event Report: CAREFUSION 2200, INC. CAREFUSION TRU-CUT BIOPSY NEEDLE; INSTRUMENT, BIOPSY

Model Number 2N2704X

Device Problem Use of Device Problem (1670)

Patient Problems Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 03/04/2020

Event Type  Injury  

Event Description

Md was performing a breast biopsy using carefusion tru-cut biopsy needle 14 g x 15 cm.Md said he felt he was "not able to control" the biopsy needle.This resulted in a puncture wound penetrating into the body cavity with pericardial effusion and tamponade.Fda safety report id# (b)(4).

• Brand Name: CAREFUSION TRU-CUT BIOPSY NEEDLE
• Type of Device: INSTRUMENT, BIOPSY
• Manufacturer (Section D): CAREFUSION 2200, INC. ; do
• MDR Report Key: 9823496
• MDR Text Key: 183342565
• Report Number: MW5093681
• Device Sequence Number: 1
• Product Code: KNW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/25/2021
• Device Model Number: 2N2704X
• Device Catalogue Number: 2N2704X
• Device Lot Number: 0000960950
• Was Device Available for Evaluation?: Yes
• 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 Outcome(s): Life Threatening
• Patient Age: 74 YR
• Patient Weight: 75