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

Model Number	2478-0000
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/07/2019
Type of Reportable Event	Malfunction
Event or Problem Description
New iv tubing package was opened and tubing was found to be broken directly above one of the port sites.No obvious rips or tears - just separated.This was discovered before reaching a patient, and no hazardous substances were spilled as the result of the tube breaking, however this tubing would have been used for chemotherapy.This will be returned for failure analysis.Manufacturer response for set, administration, intravascular, alaris, smartsite (per site reporter).The device will be returned for failure analysis.

• Brand Name: ALARIS, SMARTSITE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd.; san diego CA 92121
• MDR Report Key: 8342871
• Report Number: 8342871
• Device Sequence Number: 1923893
• Product Code: FPA
• UDI-Device Identifier: 10885403235122
• UDI-Public: (01)10885403235122
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 01/18/2019
• Report Date (Section F): 01/18/2019

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: Health Professional
• Device Model Number: 2478-0000
• Device Catalogue Number: 2478-0000
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/15/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/15/2019
• 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: 01/18/2019