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	11/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Bdmaxguard used for procedure in the invasive heart lab.When the sterile iv tubing was connected to 3 port manifold, the luerlock did not thread correctly and leaked.Despite numerous repositions, it would not quit leaking fluid.This could potentially allow air into the system and could enter a patient's heart- causing an embolism.Tubing replace with a second set- the same results.It would not quit leaking.The third set was used without further issues.No known harm to the patient, delay in procedure.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: 15923901
• Report Number: 15923901
• Device Sequence Number: 6793865
• Product Code: FPA
• UDI-Device Identifier: 10885403235825
• UDI-Public: (01)10885403235825(10)22039274(17)250322
• 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): 11/15/2022
• Report Date (Section F): 11/15/2022

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: 22039274
• 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: 12/06/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/06/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 11/15/2022