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

Catalog Number 2420-0500

Device Problem Air Leak (1008)

Patient Problem No Information (3190)

Event Date 09/21/2017

Event Type  malfunction  

Event Description

While attempting to iv push medication, bubbling was noticed in the stretchy part of the iv pump tubing.The tubing was not in the pump at the time of the event.The tubing was removed and replaced without further incident.Tubing was sent to materials and returned to manufacturer.

• Brand Name: SMARTSITE INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd.; san diego CA 92121
• MDR Report Key: 6968284
• MDR Text Key: 89940516
• Report Number: 6968284
• 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: 10/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 06/22/2020
• Device Catalogue Number: 2420-0500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2017
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/13/2017
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/13/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NOT APPLICABLE.; SYRINGE
• Patient Age: 61 YR