MAUDE Adverse Event Report: ARGON MEDICAL DEVICES, INC. L-CATHTM PICC S/L; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	28 GA (1.2F) X 25CM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During picc [peripherally inserted central catheter] line insertion the stylet was to be slightly removed to allow for complete insertion of picc line into left saphenous vein.When picc trained rn attempted to move the white "plug" on the end of the picc and stylet, the white "plug" cracked in half, allowing the stylet to be removed but leaving part of the white "plug" in the end of the picc line.This piece would need to be removed otherwise the picc would be unable to be used and unable to hook up to fluid lines.The picc trained rn was able to use jeweler to pry the white "plug" from the end of the picc.Had this not been the case, the picc would have had to be removed, therefore causing harm to the patient by needing another picc placed thus another poke, creating risk for infection and possibility of not gaining iv access needed for adequate antibiotic coverage.

• Brand Name: L-CATHTM PICC S/L
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): ARGON MEDICAL DEVICES, INC.; 1445 flat creek road; athens TX 75751
• MDR Report Key: 22977406
• Report Number: 22977406
• Device Sequence Number: 18526794
• Product Code: LJS
• UDI-Device Identifier: 00886333209910
• UDI-Public: (01)00886333209910
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/16/2025
• Report Date (Section F): 07/16/2025

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 Model Number: 28 GA (1.2F) X 25CM
• Device Catalogue Number: 384516
• Device Lot Number: 11559227
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/05/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/05/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/16/2025