MAUDE Adverse Event Report: CAREFUSION SMARTSITE NEEDLE-FREE VALVE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 2000E

Device Problems Fluid/Blood Leak (1250); Sticking (1597)

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

Event Date 08/08/2017

Event Type  malfunction  

Manufacturer Narrative

Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.

Event Description

The customer reported that after administering warmed viscous contrast fluid for 20-30 seconds via a ct injector, the smartsite valve remained compressed when the line was disconnected, resulting in leaking of blood.The contrast is injected at 5-6 ml/sec and when it cools it becomes more sticky.There is no report of injury to the patient or user as a result of this incident.

• Brand Name: SMARTSITE NEEDLE-FREE VALVE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: stephen bilello ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 6952990
• MDR Text Key: 90208314
• Report Number: 9616066-2017-01379
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K061285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2000E
• Device Catalogue Number: 2000E
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/19/2017
• Initial Date FDA Received: 10/16/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1