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	08/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is not available for return.The investigation is currently in progress.A follow-up report will be submitted upon investigation completion.
Event or Problem Description
Reporter stated ¿1.9fr picc inserted on (b)(6) 2025 found to be leaking on (b)(6) 2025.No further ivs or central lines needed for continued therapy.¿.
Additional Manufacturer Narrative
A review of the manufacturing and inspection records for this lot found no deviations or non-conformances.No samples were returned for evaluation, which limits our ability to confirm the defect through physical examination.Based on the reported description and the findings documented in (b)(4), the most likely root cause is the previously identified sealing-surface issue caused by gate vestige on the bushing¿s sealing surface.This issue was formally mitigated through a design change implemented in july 2025, which relocated the gate away from the sealing surface to eliminate leakage.The lot associated with this complaint was manufactured in december 2024, which is prior to the implementation of this design improvement, and therefore considered pre-implementation.The failure mode has already been addressed by the updated design.Because the root cause has been mitigated and this lot predates the change, no further action is required at this time.If the device becomes available in the future, we will reopen the complaint for further evaluation.Additional information provided in h.6.And h.11.

• 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 75751
• Manufacturer Contact: kelly mayer ; 1445 flat creek road; athens, TX 75758 ; 9036759321
• MDR Report Key: 23479099
• Report Number: 0001625425-2025-01124
• Device Sequence Number: 10228266
• Product Code: LJS
• UDI-Device Identifier: 00886333209934
• UDI-Public: (01)00886333209934(17)271114(10)11598928
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2026

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: 11598928
• Was Device Available for Evaluation?: No
• 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: 10/06/2025
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/30/2024
• 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
• Patient Sex: Unknown