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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 16027055
Device Problem Sticking (1597)
Patient Problem No Code Available (3191)
Event Date 06/21/2016
Event Type  Injury  
Event Description
While changing the picc dressing and injection caps, the proximal white lumen was noted to have the center plastic piece of the chemo cap floating/lodged in lumen. Several attempts were made to remove the plastic part without success. Picc had to be removed and patient is scheduled to have another picc line done.
 
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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 Key5754547
MDR Text Key48302049
Report Number5754547
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
Type of Report Initial
Report Date 06/24/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/01/2019
Device Lot Number16027055
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/24/2016
Device Age5 DY
Event Location Hospital
Date Report to Manufacturer06/24/2016
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

Patient Treatment Data
Date Received: 06/28/2016 Patient Sequence Number: 1
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