MAUDE Adverse Event Report: ARGON MEDICAL DEVICES FIRST PICC S/L 26GA (1.9F) 0.65MM X 50CM

Catalog Number 384232

Device Problem Fluid/Blood Leak (1250)

Patient Problem Swelling (2091)

Event Date 03/08/2020

Event Type  malfunction  

Manufacturer Narrative

The sample device was indicated as available for evaluation.Argon has made three good faith efforts in requesting the return of the device, however, as of the date of this report the device has not yet been returned.Without such evidence, a root cause cannot be determined.If additional information is received in the future, the issue will be re-evaluated as needed.

Event Description

Picc inserted (b)(6) 2020.Picc removed (b)(6) 2020 due to leaking at insertion site and swollen shoulder.

• Brand Name: FIRST PICC S/L 26GA (1.9F) 0.65MM X 50CM
• Type of Device: FIRST PICC
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• MDR Report Key: 9951066
• MDR Text Key: 188207904
• Report Number: 1625425-2020-00284
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): Y
• PMA/PMN Number: K972262
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 384232
• Device Lot Number: 11276377
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 03/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other