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

Model Number	10794983
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Received patient at start of shift with pac infusing.5 port ivf tubing connected to bifurcate extension, connected to phasal, connected to heparin cap and patient's pac.Shortly after, bifurcate extension set found broken with tubing snapped below male connection.Male connection remained attached to phasal.Female connection intact with ivf tubing.

• Brand Name: ALARIS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd; san diego CA 92121
• MDR Report Key: 11462262
• Report Number: 11462262
• Device Sequence Number: 3522207
• Product Code: FPA
• UDI-Device Identifier: 10885403234293
• UDI-Public: (01)10885403234293
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/11/2021
• Report Date (Section F): 02/11/2021

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: 10794983
• Device Catalogue Number: 10794983
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/10/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/11/2021
• 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: 02/11/2021