MAUDE Adverse Event Report: ARGON MEDICAL DEVICES L-CATH 26GA (1.9F) 0.60MM X 30CM; CATHETER INTRAVASCULAR, THERAPEUTIC

Model Number	384539
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2025
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
A customer reported that a picc was inserted into an infant during a procedure.The guidewire had resistance when trying to remove and the catheter was "scrunching/buckling." tension released and purple stabilizer at cannula broke off and slid down line.Line removed immediately.

• Brand Name: L-CATH 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: 23700931
• Report Number: 0001625425-2025-01152
• Device Sequence Number: 21495166
• Product Code: LJS
• UDI-Device Identifier: 00886333209934
• UDI-Public: (01)00886333209934(17)271206(10)11601469
• 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): 05/13/2026

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: 11601469
• 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: 11/03/2025
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/17/2025
• 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
• Patient Sex: Unknown