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

Model Number	ME2068
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/02/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Nicu infant was receiving transfusion of prbc.Blood transfusion was running when the tubing was found to be leaking.A crack was noted at connection site.

• 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: 8811200
• Report Number: 8811200
• Device Sequence Number: 16693353
• Product Code: FPA
• UDI-Device Identifier: 10885403236297
• UDI-Public: (01)10885403236297
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/16/2019
• Report Date (Section F): 07/16/2019

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: No Information
• Device Model Number: ME2068
• Device Catalogue Number: ME2068
• Device Lot Number: 18095123
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 07/22/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 7 DA
• Date Report Sent to FDA: 07/16/2019