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

Model Number 2420-0500

Device Problem Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 01/08/2021

Event Type  malfunction  

Event Description

Iv tubing spontaneously fell apart.

• Brand Name: ALARIS, SMARTSITE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd; san diego CA 92121
• MDR Report Key: 12512114
• MDR Text Key: 272764671
• Report Number: 12512114
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 09/14/2021,01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2420-0500
• Device Catalogue Number: 2420-0500
• Device Lot Number: 20123011
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/14/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 12045 DA