MAUDE Adverse Event Report: ARGON MEDICAL DEVICES 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	10/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A risk manager reported ¿l-cath picc 26 gauge, leaking at the edges at the top of the catheter right after placement.Line pulled before taped down and restarted.This is an on and off again problem with these catheters¿.
Additional Manufacturer Narrative
The sample is indicated as available for return.As of the date of this report, the sample has not been returned.A follow-up report will be provided once the device has been received and reviewed.

• 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; 1445 flat creek road; athens TX 75758
• Manufacturer Contact: kelly mayer ; 1445 flat creek road; athens, TX 75758 ; 9036759321
• MDR Report Key: 23799900
• Report Number: 0001625425-2025-01157
• Device Sequence Number: 18489175
• Product Code: LJS
• UDI-Device Identifier: 00886333209934
• UDI-Public: (01)00886333209934(17)280117(10)11603831
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K230669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/14/2025

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
• Operator of Device: Health Professional
• Device Model Number: 384539
• Device Lot Number: 11603831
• Was Device Available for Evaluation?: Yes
• 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: 11/14/2025
• Initial Report FDA Received Date: 12/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/18/2025
• 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
• Patient Age: 2 DA
• Patient Sex: Male