MAUDE Adverse Event Report: Argon Medical Devices, Inc L-Cath PICC S/L 28GA (1.2F) x 25cm 1 Lumen); Catheter Intravascular, Therapeutic

Model Number	384516
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	11/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Reporter stated that since the new design of the 28g argon catheters, the extension/picc connection has been leaking repeatedly, even though the extension ring remains screwed on, regardless of the catheter batch number.The impact included loss of the catheter and time for reinsertion of a new picc line.Re-sedation and pain/discomfort for the baby.Additional time required for the procedure.
Additional Manufacturer Narrative
The complaint sample has been returned for investigation and is currently in process.A follow up report will be submitted upon the closure of the investigation.

• Brand Name: L-Cath PICC S/L 28GA (1.2F) x 25cm 1 Lumen)
• Common Device Name: Catheter Intravascular, Therapeutic
• Manufacturer (Section D): Argon Medical Devices, Inc; 1445 flat creek road; athens TX 75751
• Manufacturer Contact: kelly mayer ; 1445 flat creek road; athens, TX 75751 ; +1(903)675-9321
• MDR Report Key: 50074667
• Report Number: 0001625425-2026-00994
• Device Sequence Number: 13325388
• Product Code: LJS
• UDI-Device Identifier: 00886333209910
• UDI-Public: 00886333209910
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K091670
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/29/2026

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
• Operator of Device: Health Professional
• Device Model Number: 384516
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/21/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2026
• Initial Report FDA Received Date: 07/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown