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

Catalog Number 384232

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Phlebitis (2004); Swelling (2091); Skin Inflammation (2443)

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 was inserted on (b)(6) 2020 at 1600 with no complications.On (b)(6) 2020 at 1500 phlebitis was noted next to the insertion site.Warm compress was applied and the leg was elevated, md ordered to continue to assess the patients leg and monitor for improvement.On (b)(6) 2020 when md reassessed picc line, no improvement was seen, the redness was worse, cord could be felt along the picc line and near the insertion and the swelling was more significant.Md ordered the picc to be removed.The picc line was removed successfully, no leak noted after removal.

Event Description

Follow up.

• 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: 9951051
• MDR Text Key: 187777622
• Report Number: 1625425-2020-00281
• 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

• 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
• Initial Date Manufacturer Received: 03/12/2020
• Initial Date FDA Received: 04/10/2020
• Supplement Dates Manufacturer Received: 03/12/2020
• Supplement Dates FDA Received: 05/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other