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	Insufficient Information (4580)
Date of Event	11/07/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Customer reported "line placed on (b)(6) 2025 and started leaking during use on (b)(6) 2025.They have holes and/or broke where the purple met the catheter and shred." medical intervention was reported.

• 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: 23894413
• Report Number: 0001625425-2025-01161
• Device Sequence Number: 4438383
• Product Code: LJS
• UDI-Device Identifier: 00886333209934
• UDI-Public: (01)00886333209934(17)280326(10)11613894
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K230669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 12/25/2025

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: 11613894
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 12/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/28/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 11 DA
• Patient Sex: Female
• Patient Weight: 2 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American