MAUDE Adverse Event Report: ARGON MEDICAL DEVICES L-CATH PICC S/L BASIC KIT 28GA (1.2F) X 25CM 1 LUMEN); CATHETER INTRAVASCULAR, THERAPEUTIC

Model Number	384516
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample was returned to argon for investigation.The investigation is currently in progress.A follow-up report will be submitted upon investigation completion.
Event or Problem Description
Picc found to be leaking at the connection site after being placed in the patient.Unexpected/prolonged care was required.There was no patient injury.
Additional Manufacturer Narrative
After thoroughly reviewing the manufacturing and inspection records for this lot, we found no deviations or non-conformances.One sample was returned for evaluation.Upon visual inspection, there was no damage found to the catheter or catheter hub.During functional testing¿performed by crimping the tubing with a hemostat¿a leak was detected originating from the threads of the male to female luer connection.The complaint is confirmed.The most likely cause of the leakage is an occlusion at the connection between the female luer lock and the catheter tubing.This issue has been escalated to the sustaining engineering team for further investigation into the root cause of this issue.Argon will continue to monitor for similar reports.Additional information provided in h.3., h.6.And h.11.

• Brand Name: L-CATH PICC S/L BASIC KIT 28GA (1.2F) X 25CM 1 LUMEN)
• Common Device Name: CATHETER INTRAVASCULAR, THERAPEUTIC
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek road; athens TX 75751
• Manufacturer Contact: kelly mayer ; 1445 flat creek road; athens, TX 75751 ; 9036759321
• MDR Report Key: 21955469
• Report Number: 0001625425-2025-01001
• Device Sequence Number: 20639901
• Product Code: LJS
• UDI-Device Identifier: 00886333209910
• UDI-Public: (01)00886333209910(17)271001(10)11600231
• Combination Product (Y/N): N
• 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: Foreign,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2025

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: 384516
• Device Lot Number: 11600231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2025
• 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: 04/03/2025
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2024
• 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: Other
• Patient Sex: Unknown