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

Model Number 2123-0007

Device Problems Air Leak (1008); Fluid/Blood Leak (1250)

Patient Problem No Information (3190)

Event Date 05/08/2016

Event Type  malfunction  

Event Description

There were air bubbles in patients iv line, nurse used a syringe with a blunt needle on it and accessed a port on the iv line to remove air bubbles.When syringe was removed from port the rubber part where the needle goes into, was pushed down and the drug that was in the line started to leak out.The whole line needed to be changed.

• Brand Name: ALARIS, VERSASAFE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd.; san diego CA 92121
• MDR Report Key: 6710138
• MDR Text Key: 79945483
• Report Number: 6710138
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 2123-0007
• Device Catalogue Number: 2123-0007
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/30/2017
• Event Location: Hospital
• Date Report to Manufacturer: 06/30/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 54 YR