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

Model Number 20039E

Device Problems Difficult to Flush (1251); Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 08/09/2021

Event Type  malfunction  

Event Description

Prior to connecting to an established iv access; attempts were made to flush with ns.Total resistance was met and unable to flush device.

• Brand Name: ALARIS SMARTSITE EXTENSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd.; san diego CA 92121
• MDR Report Key: 12318086
• MDR Text Key: 266413762
• Report Number: 12318086
• 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: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20039E
• Device Catalogue Number: 20039E
• Device Lot Number: 21085555
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/10/2021
• Date Report to Manufacturer: 08/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1