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	11/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Bd maxguard 10 drop admin set- when this sterile iv tubing is connected to a stopcock, it leaks around the threading even if it is threaded/tightly correctly.This line is connected to a sheath that goes into the left atrium of the heart and could introduce air if the tubing is leaking.We connect this tubing to a bag of fluid under pressure.I cannot include the fluid bag and pressure bag because we switch out the tubing and continue to use the fluid bag under pressure.We always check this connection before the iv tubing is ever connected to the sheath (connected to the patient).This is event number 5 for this same product- please refer to 2022-8109, 2022-8110 and 2022-8112.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: 15949682
• Report Number: 15949682
• Device Sequence Number: 20473448
• 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): 11/30/2022
• Report Date (Section F): 11/30/2022

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
• 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: 12/09/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/09/2022
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 11/30/2022