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U.S. Department of Health and Human Services

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

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CAREFUSION SMARTSITE NEEDLE-FREE VALVE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 2000E
Device Problems Fluid 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 5-6ml/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.
 
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Brand NameSMARTSITE NEEDLE-FREE VALVE
Type of DeviceSET, 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 Key6953079
MDR Text Key89865766
Report Number9616066-2017-01378
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K061285
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Reporter Occupation
Type of Report Initial
Report Date 09/19/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/16/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2000E
Device Catalogue Number2000E
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/19/2017
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

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