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

Model Number 2000E

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/24/2020

Event Type  malfunction  

Event Description

I started a 20g iv for the patient and connected the bd smartsite needle-free valve lot (10) 19125945 to the iv catheter hub.I tried to aspirate blood for a lab sample using a 10ml syringe, with no blood return.I connected a vacutainer to attempt to obtain blood sample with no blood return.I attempted to flush the iv, and it would not work.I checked the connection between the catheter hub and the smartsite needle-free valve and it was connected correctly and secure.There was blood in the catheter hub up until the needle-free valve.I then changed the bd smartsite needle-free valve for a new one and was able to obtain the blood sample and flush the iv without resistance.

Event Description

I started a 20g iv for the patient and connected the bd smartsite needle-free valve lot (10) 19125945 to the iv catheter hub.I tried to aspirate blood for a lab sample using a 10ml syringe, with no blood return.I connected a vacutainer to attempt to obtain blood sample with no blood return.I attempted to flush the iv, and it would not work.I checked the connection between the catheter hub and the smartsite needle-free valve and it was connected correctly and secure.There was blood in the catheter hub up until the needle-free valve.I then changed the bd smartsite needle-free valve for a new one and was able to obtain the blood sample and flush the iv without resistance.

• Brand Name: ALARIS, SMARTSITE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd.; san diego CA 92121
• MDR Report Key: 10762634
• MDR Text Key: 213878465
• Report Number: 10762634
• 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,Followup
• Report Date: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 2000E
• Device Catalogue Number: 2000E
• Device Lot Number: 19125945
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/23/2020
• Date Report to Manufacturer: 10/30/2020
• Patient Sequence Number: 1