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

Model Number CA1411

Device Problems Bent (1059); Out-Of-Box Failure (2311)

Patient Problem No Information (3190)

Event Date 06/13/2018

Event Type  malfunction  

Event Description

Upon opening of package, a bent biopsy needle was identified.

• 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: 7628903
• MDR Text Key: 112001694
• Report Number: 7628903
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/02/2022
• Device Model Number: CA1411
• Device Catalogue Number: CA1411
• Device Lot Number: 0001197580
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/20/2018
• Device Age: 1 DY
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 06/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO