MAUDE Adverse Event Report: ARGON MEDICAL DEVICES L-CATH PICC S/L18GA (3.5F) 1.15MM X 60CM; CATHETER INTRAVASCULAR, THERAPEUTIC

Model Number	384464
Medical Device Problem Codes	Crack (1135); Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Reporter states 7 piccs from this lot were cracked/leaking at the hub.
Additional Manufacturer Narrative
After a thorough review of the manufacturing and inspection records for this lot, no deviations or non-conformances were identified.A total of 71 units were returned for evaluation.Functional testing was conducted on 13 of these units by crimping the tubing with a hemostat to assess for leakage.Leakage was observed from the hub during testing; the complaint is confirmed.The most probable root cause is the presence of gate vestige on the sealing surface, which likely contributed to sealing inconsistencies and made the hub susceptible to leakage.To address this issue, (b)(4) was completed to relocate the gate away from the sealing surface.This redesign eliminates the potential for gate vestige to interfere with sealing integrity.Additional information provided in h.3., h.6.And h.11.

• Brand Name: L-CATH PICC S/L18GA (3.5F) 1.15MM X 60CM
• 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: 21990526
• Report Number: 0001625425-2025-01008
• Device Sequence Number: 15532000
• Product Code: LJS
• UDI-Device Identifier: 00886333209835
• UDI-Public: (01)00886333209835(17)271005(10)11594450
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2026

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: 384464
• Device Lot Number: 11594450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2025
• Supplement Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2024
• 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