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U.S. Department of Health and Human Services

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

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CAREFUSION 303, INC. ALARIS, SMARTSITE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 2420-0007
Device Problem Material Deformation (2976)
Patient Problem Insufficient Information (4580)
Event Date 06/19/2021
Event Type  malfunction  
Event Description
Rn tried to prime the bag of iv fluid, but the tubing was kinked and unusable. Defect in tubing is visible.
 
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Brand NameALARIS, SMARTSITE
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION 303, INC.
10020 pacific mesa blvd
san diego CA 92121
MDR Report Key12074676
MDR Text Key258634038
Report Number12074676
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 06/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2420-0007
Device Catalogue Number2420-0007
Device Lot Number21045699
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/21/2021
Event Location Hospital
Date Report to Manufacturer06/28/2021
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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