MAUDE Adverse Event Report: ARGON MEDICAL DEVICES, INC L-CATH PICC S/L PERIPHERALLY INSERTED CENTRAL CATHETER 26GA (1.9F) 0.60MM X 30CM; CATHETER INTRAVASCULAR, THERAPEUTIC

Model Number	384539
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
¿pt had a 1.9fr argon l-cath picc [peripherally inserted central catheter] line placed on [redacted] at the r [right] knee.It had been infusing tpn/lipids [total parenteral nutrition].Today, the bedside nurse alerted the rnts [rapid response nursing team/teams] that the dressing was no longer occlusive.¿ ¿rnts arrived at bedside prepared to do a dressing change.Once the dressing was removed, the rnts could see the saturated hub cushion which smelled like tpn.Upon further investigation of the line, the rnts could see a pin-prick rupture at the junction of the catheter and purple sheath.Bedside rn notified medical team of ruptured catheter and need for new picc.Mom was at bedside and able to consent.Order placed for new picc line.Rnts able to cut line and re-wire catheter and replace with new picc line.¿ r¿compare lot number of this catheter with other recent catheter ruptures and contact manufacture to update.¿ ¿second picc from same lot broken.¿.

• Brand Name: L-CATH PICC S/L PERIPHERALLY INSERTED CENTRAL CATHETER 26GA (1.9F) 0.60MM X 30CM
• 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: 24478837
• Report Number: 0001625425-2026-00943
• Device Sequence Number: 13325628
• Product Code: FOZ
• UDI-Device Identifier: 00886333209934
• UDI-Public: (01)00886333209934(17)270612(10)11601469
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/28/2026

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/14/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 2 MO
• Patient Sex: Male