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U.S. Department of Health and Human Services

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

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CAREFUSION 303, INC. SMARTSITE INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 2426-0007
Device Problem Device Slipped (1584)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/19/2016
Event Type  malfunction  
Manufacturer Narrative
Unique device identifier (udi): for type of device: set, administration, intravascular.
 
Event Description
While transporting the patient down the hall, the ct tech said they went over a bump and the tubing popped off. It was not pulled on at all.
 
Event Description
While transporting the patient down the hall, the ct tech said they went over a bump and the tubing popped off. It was not pulled on at all.
 
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Brand NameSMARTSITE INFUSION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION 303, INC.
10020 pacific mesa blvd.
san diego CA 92121
MDR Report Key6010494
MDR Text Key114973510
Report Number6010494
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial,Followup
Report Date 09/27/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/07/2016
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? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/27/2016
Device Age1 YR
Event Location Hospital
Date Report to Manufacturer09/27/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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