MAUDE Adverse Event Report: ARGON MEDICAL DEVICES L-CATH PICC S/L 20GA (3F) 1.00MM X 60CM; CATHETER INTRAVASCULAR, THERAPEUTIC

Model Number	384463
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
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
The reporter states they have found broken/cracked piccs from 4 different lots.No details were provided about type of procedure, quantity of piccs, dates of occurrence, no injury was reported.
Additional Manufacturer Narrative
A review of the manufacturing and inspection records for this lot was conducted, and no deviations or non-conformances were recorded relating to this issue.There were 79 sealed samples were returned to argon from the customer.A visual inspection was performed on the returned product.The visual inspection determined that 26/79 returned samples were found with cracks on the female luer lock hub.The cracking of the female luer lock is due to a weld-line (or knit-line) located at a high-stress area of the part.This stress is generated during normal use when the male component is tightened into the female part, creating a sealing force.The presence of the weld-line at this stress point introduces a structural weakness, making the part more susceptible to cracking.To address this issue, a capa and dcr were initiated and successfully implemented.These actions included the introduction of a new material specifically selected to improve the structural integrity of the female luer lock.Please note that the lot associated with this complaint was manufactured prior to the implementation of these corrective actions.Argon will continue to monitor for similar reports.Additional information provided in d.9., h.3., h.6., h.10.And h.11.

• Brand Name: L-CATH PICC S/L 20GA (3F) 1.00MM 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: 21989657
• Report Number: 0001625425-2025-01004
• Device Sequence Number: 20911227
• Product Code: LJS
• UDI-Device Identifier: 00886333209828
• UDI-Public: (01)00886333209828(17)251026(10)11445879
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2025

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 Expiration Date: 10/26/2025
• Device Model Number: 384463
• Device Lot Number: 11445879
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/29/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2022
• 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