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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION 303, INC. AS LVP 20D 1.2M SET, ADMINISTRATION, INTRAVASCULAR

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CAREFUSION 303, INC. AS LVP 20D 1.2M SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 2202-0007
Device Problem Gas/Air Leak (2946)
Patient Problem Irritability (2421)
Event Date 11/16/2020
Event Type  No Answer Provided  
Event Description
Patient's picc line tubing was changed in evening for line change day. Patient was fussy and while trying to settle baby discovered air bubble that was significantly large at the base of filter. Filter was not functioning properly and bubbles were passing through. Had to pull from the line to remove air bubble.
 
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Brand NameAS LVP 20D 1.2M
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION 303, INC.
10020 pacific mesa blvd.
san diego CA 92121
MDR Report Key11100360
MDR Text Key224531367
Report Number11100360
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 Other Health Care Professional
Type of Report Initial
Report Date 12/01/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model Number2202-0007
Device Catalogue Number2202-0007
Device Lot Number20075125
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/01/2020
Event Location Hospital
Date Report to Manufacturer12/31/2020
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?
Type of Device Usage Unkown

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