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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON ARGON ARGON PICC LINE

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ARGON ARGON ARGON PICC LINE Back to Search Results
Model Number 26 GA
Device Problem Migration or Expulsion of Device (1395)
Patient Problem Death (1802)
Event Date 02/03/2016
Event Type  Death  
Event Description
Infant had a picc line placed on (b)(6) 2016, which was noted to have migrated into the heart and reposition on the occasions. On (b)(6) 2016, infant had a sudden arrest and expired. Autopsy revealed a pericardial effusion with fluid consistent with total parenteral nutrition solution.
 
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Brand NameARGON
Type of DeviceARGON PICC LINE
Manufacturer (Section D)
ARGON
5151 headquarters drive
ste 210
plano TX 75024
MDR Report Key5479606
MDR Text Key39666207
Report Number5479606
Device Sequence Number1
Product Code FOZ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 02/12/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number26 GA
Device Lot Number11122897
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/12/2016
Distributor Facility Aware Date02/03/2016
Event Location Hospital
Date Report to Manufacturer02/12/2016
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 02/17/2016 Patient Sequence Number: 1
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