MAUDE Adverse Event Report: Argon Medical Devices, Inc L-Cath PICC S/L 28GA (1.2F) x 25cm 1 Lumen); Filter, Intravascular, Cardiovascular

Model Number	384516
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Occurred less than 24h post insertion: picc line leaking despite hub being tightened and dressing redressed, entire dressing saturated and lifting off less than 30 minutes post dressing change.Discussed with neonatologist, plan to rewire picc with new line.Cleaned and draped in usual fashion.Dilator introduced without incidence.Gentle steady pressure used to withdraw line with moderate resistance felt.Leg massaged while firm, but gentle pressure applied to line.Line spontaneously snapped with no line exposed.A total of 8 cm of line broke off/ removed from infant.Line initially trimmed to 20 cm at time of insertion; therefore, 12 cm left inside infant.Neonatologist aware of line snapping immediately.Unexpected or prolonged care was required.It is unknown if there was patient impact.
Additional Manufacturer Narrative
It is unknown if the sample is available.As of the date of this report, the sample has not been returned.A follow-up report will be submitted upon investigation completion.

• Brand Name: L-Cath PICC S/L 28GA (1.2F) x 25cm 1 Lumen)
• Common Device Name: Filter, Intravascular, Cardiovascular
• Manufacturer (Section D): Argon Medical Devices, Inc; 1445 flat creek road; athens TX 75751
• Manufacturer Contact: kelly mayer ; 1445 flat creek road; athens, TX 75751 ; +1(903)675-9321
• MDR Report Key: 50948238
• Report Number: 0001625425-2026-01023
• Device Sequence Number: 9624443
• Product Code: LJS
• UDI-Device Identifier: 00886333209910
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K091670
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: 11658080
• 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: 08/31/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/25/2026
• 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