MAUDE Adverse Event Report: CAREFUSION 2200, INC ACHIEVE; INSTRUMENT, BIOPSY

Catalog Number CA1411

Device Problems Contamination (1120); Mechanical Jam (2983)

Patient Problem Tissue Damage (2104)

Event Date 01/22/2020

Event Type  malfunction  

Event Description

The coaxial achieve biopsy needle malfunctioned during a procedure.The device became stuck in the patient's breast for a brief second and upon removal of the device the sample was jammed inside.The radiologist had to use significant force to open the device causing the specimen to fly out into the patients table.This was the third core specimen which became contaminated, so it was disposed of and dr.Repeated to get the 3rd specimen.

• Brand Name: ACHIEVE
• Type of Device: INSTRUMENT, BIOPSY
• Manufacturer (Section D): CAREFUSION 2200, INC; 75 north fairway drive; vernon hills IL 60061
• MDR Report Key: 9726768
• MDR Text Key: 179949499
• Report Number: 9726768
• Device Sequence Number: 1
• Product Code: KNW
• 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: 01/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CA1411
• Device Lot Number: 0001292453
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/23/2020
• Event Location: Hospital
• Date Report to Manufacturer: 02/19/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 21900 DA
• Patient Weight: 54