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

Model Number	MS3500-15
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly male with history of meckel¿s diverticulitis and recent abdominal pain.Procedure: infusion of zosyn.The plastic tip of the secondary tubing was found to be broken off and inside the bag of zosyn.No known harm to patient.

• 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: 18628929
• Report Number: 18628929
• Device Sequence Number: 7963740
• Product Code: FPA
• UDI-Device Identifier: 10885403222610
• UDI-Public: (01)10885403222610(17)20261115(10)23119196
• 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): 01/24/2024
• Report Date (Section F): 01/24/2024

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: MS3500-15
• Device Catalogue Number: MS3500-15
• Device Lot Number: 23119196
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/02/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/02/2024
• 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: Male
• Patient Weight: 77 KG
• Date Report Sent to FDA: 01/24/2024