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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION 303, INC. SMARTSITE NEEDLE-FREE VALVE SET, ADMINISTRATION, INTRAVASCULAR

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CAREFUSION 303, INC. SMARTSITE NEEDLE-FREE VALVE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Lot Number (10)20085925
Device Problems Break (1069); Defective Device (2588); Material Deformation (2976)
Patient Problem Insufficient Information (4580)
Event Date 03/10/2021
Event Type  malfunction  
Event Description
Pt received chemotherapy (daunorubicin-cytarabine liposomal) and nacl flush without complications. Upon rn disconnecting, noted syringe appeared tilted while flushing fluid. No leaking occurring. Rn attempted to reattach syringe to secure connection. At this time rn noted the valve itself was tilted; when writer tried to disconnect syringe to change valves the valve came apart while attached to pt. The white portion still connected with clear and soft blue section still connected came apart from clear leurlock connected to syringe. Writer quickly changed broken valve with new valve and flushed without complication. Updated charge nurse and gave them the defective valve.
 
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Brand NameSMARTSITE NEEDLE-FREE VALVE
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION 303, INC.
10020 pacific mesa blvd.
san diego CA 92121
MDR Report Key11574428
MDR Text Key242412734
Report Number11574428
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 03/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number(10)20085925
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/10/2021
Event Location Outpatient Treatment Facility
Date Report to Manufacturer03/26/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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