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

Model Number	FRA2015
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Carefusion product fra2015, a fine needle for aspiration opened for a procedure had a creased bend and unable to use device.A second was opened for use without any bend.No harm or delay to patient.

• Brand Name: TEMNO
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): CAREFUSION 2200, INC; 75 north fairway drive; vernon hills IL 60061
• MDR Report Key: 13548381
• Report Number: 13548381
• Device Sequence Number: 5236136
• Product Code: KNW
• UDI-Device Identifier: 10885403089558
• UDI-Public: (01)10885403089558
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/09/2022
• Report Date (Section F): 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: FRA2015
• Device Catalogue Number: FRA2015
• Device Lot Number: 0001378041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/17/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/17/2022
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/09/2022