MAUDE Adverse Event Report: ARGON ARGON; ARGON PICC LINE

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.

• Brand Name: ARGON
• Type of Device: ARGON PICC LINE
• Manufacturer (Section D): ARGON ; 5151 headquarters drive; ste 210; plano TX 75024
• MDR Report Key: 5479606
• MDR Text Key: 39666207
• Report Number: 5479606
• Device Sequence Number: 1
• Product Code: FOZ
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 26 GA
• Device Lot Number: 11122897
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/12/2016
• Distributor Facility Aware Date: 02/03/2016
• Event Location: Hospital
• Date Report to Manufacturer: 02/12/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/17/2016
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death