MAUDE Adverse Event Report: ARGON MEDICAL DEVICES, INC FIRST PICC S/L 26GA (1.9F) 0.65MM X 50CM; CATHETER INTRAVASCULAR, THERAPEUTIC

Model Number	384232
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
¿dressing on picc noted to be wet.Both cotton balls and steri strips were wet.Under the tegaderm dressing was dry.Nnp notified.Upon nnp aspirating off the line, fluids noted to be leaking from the thickened part of the picc above the hubb.Picc dc'd and peripheral line placed.Once picc removed, fluids were flushed through the catheter and a split was noted in the catheter with fluids leaking.Catheter saved.Date of insertion ¿ (b)(6) 2026.Piv placed to continue therapy.¿.
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.

• Brand Name: FIRST PICC S/L 26GA (1.9F) 0.65MM X 50CM
• Common Device Name: CATHETER INTRAVASCULAR, THERAPEUTIC
• 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 ; 9036759321
• MDR Report Key: 25062550
• Report Number: 0001625425-2026-00959
• Device Sequence Number: 15977740
• Product Code: FOZ
• UDI-Device Identifier: 00886333209750
• UDI-Public: (01)00886333209750(17)280421(10)11616920
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K972262
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/01/2026

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: 384232
• Device Lot Number: 11616920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2026
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 05/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/28/2025
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown