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

Model Number 15095490

Device Problem Material Disintegration (1177)

Patient Problem No Information (3190)

Event Date 10/16/2015

Event Type  malfunction  

Event Description

When using our primary infusion iv tubing, the luer lock end crumbled and fell apart when connecting the tubing to the patient.

• Brand Name: SMARTSITE PRIMARY 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: 5387507
• MDR Text Key: 36723052
• Report Number: 5387507
• 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: 12/29/2015,01/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Expiration Date: 09/01/2018
• Device Model Number: 15095490
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/29/2015
• Event Location: Hospital
• Date Report to Manufacturer: 12/29/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 93