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

Model Number	MZ8002
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/25/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Tubing missing blue slider clamp.This is a safety clamp that should be present.7 packages missing blue slider clamp.

• Brand Name: MAXZERO
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd.; san diego CA 92121
• MDR Report Key: 10835822
• Report Number: 10835822
• Device Sequence Number: 3595278
• Product Code: FPA
• UDI-Device Identifier: 10885403246913
• UDI-Public: (01)10885403246913
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 10/28/2020
• Report Date (Section F): 10/28/2020

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: MZ8002
• Device Catalogue Number: MZ8002
• Device Lot Number: 18075163
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/13/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 10/28/2020