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U.S. Department of Health and Human Services

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

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CAREFUSION 303, INC. SMARTSITE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 2426-0007
Device Problems Contamination (1120); Material Separation (1562)
Patient Problem Insufficient Information (4580)
Event Date 07/15/2021
Event Type  malfunction  
Event Description
Upon entering room to check piv and carfilzomib infusion, tubing gently moved and immediately the tubing came apart at the y-site closest to the patient. Both the tubing with carfilzomib and iv extension set were immediately clamped. Infusion was unable to be restarted as tubing had been contaminated. Noted 8. 13 ml volume to be infused with 2 minutes left to complete infusion. No harm to patient except that they were not able to receive entire dose of medication. Md and clinical research coordinator notified. Tubing: bd alaris pump infusion set 3 smartsite y-sites; ref 2426-0007. Product not saved as hazardous category i product in line.
 
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Brand NameSMARTSITE
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION 303, INC.
10020 pacific mesa blvd.
san diego CA 92121
MDR Report Key12300497
MDR Text Key265795227
Report Number12300497
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 07/26/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2426-0007
Device Catalogue Number2426-0007
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/26/2021
Event Location Outpatient Treatment Facility
Date Report to Manufacturer08/10/2021
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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