MAUDE Adverse Event Report: Argon Medical Devices, Inc L-Cath PICC S/L 26ga (1.9F) 0.60mm x 30cm; Catheter Intravascular, Therapeutic

Model Number	384539
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Reporter stated picc line inserted on june 13th.Noted to be leaking with dressing changes on june 16th and 17th.On june 17th when dressing taken down and line flushed, there was leaking noted from catheter hub to purple extension piece (all part of sterile part of picc line), therefore the line was damaged and needed to be replaced.No apparent harm - reached the patient/person.
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 26ga (1.9F) 0.60mm x 30cm
• 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: 50009937
• Report Number: 0001625425-2026-00992
• Device Sequence Number: 5841109
• Product Code: LJS
• UDI-Device Identifier: 00886333209934
• UDI-Public: (01)00886333209934(17)271120(10)11599613
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K230669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/23/2026

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: 384539
• Device Lot Number: 11599613
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/21/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/16/2024
• 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