MAUDE Adverse Event Report: CAREFUSION 303, INC. MAXGUARD; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	MA3131
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Late 60¿s female with history of atrial fibrillation.Procedure: ablation af.Maxguard 10cc drop administration tubing leading at the leuer lock hub.The tubing is sterile and connected to a side port of a sheath that extends into the left atrium of the heart.This could potentially introduce air into the body.Tubing removed without difficulty and a new set used.No known harm to patient.Manufacturer response for set, administration, intravascular, maxguard (per site reporter) will obtain.

• Brand Name: MAXGUARD
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd; san diego CA 92121
• MDR Report Key: 16536628
• Report Number: 16536628
• Device Sequence Number: 5946256
• Product Code: FPA
• UDI-Device Identifier: 10885403235825
• UDI-Public: (01)10885403235825(10)22069490(17)250623
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 02/20/2023
• Report Date (Section F): 02/20/2023

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
• Operator of Device: Health Professional
• Device Model Number: MA3131
• Device Catalogue Number: MA3131
• Device Lot Number: 22069490
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/14/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/14/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Date Report Sent to FDA: 02/20/2023