MAUDE Adverse Event Report: CAREFUSION 303, INC ALARIS; IV TUBING

Model Number 2420-0007

Device Problems Detachment Of Device Component (1104); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/19/2014

Event Type  malfunction  

Event Description

The nurse (rn) was trying to start an intravenous (iv) with primary tubing and the iv tubing came off of the iv chamber and the iv fluid came out on to the floor.No harm to patient and/or rn.

• Brand Name: ALARIS
• Type of Device: IV TUBING
• Manufacturer (Section D): CAREFUSION 303, INC; 10020 pacific mesa blvd; san diego CA 92121
• MDR Report Key: 3644103
• MDR Text Key: 4210291
• Report Number: 3644103
• Device Sequence Number: 1
• Product Code: FPK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 02/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/21/2014
• Event Location: Hospital
• Date Report to Manufacturer: 02/25/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1