MAUDE Adverse Event Report: ARGON MEDICAL DEVICES INC. FIRST PICC; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number 384516

Device Problem Insufficient Information (3190)

Patient Problem Pleural Effusion (2010)

Event Date 05/05/2016

Event Type  malfunction  

Event Description

Infants with picc's developed infiltrates and/or pleural effusion.Four episodes to date.Hospital performing root cause analysis (rca).

• Brand Name: FIRST PICC
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): ARGON MEDICAL DEVICES INC.; 1445 flat creek rd; athens, TX 75751
• MDR Report Key: 5750684
• MDR Text Key: 48229469
• Report Number: 5750684
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 384516
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/06/2016
• Event Location: Hospital
• Date Report to Manufacturer: 06/06/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1