MAUDE Adverse Event Report: ARGON MEDICAL DEVICES, INC. L-CATHTM PICC S/L; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	28 GA (1.2F) X 25CM
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	07/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was noted that the argon picc [peripherally inserted central catheter] was leaking.See procedure note for lot number.After the leaking was noted, this rn and [redacted] were attempting to find where the leak was coming from.The t connector was intact and secure, but leaking was noted at the t connector/picc connection.After changing the t connector (bd maxzero), taking off the posi flow, we were unable to flush the picc as it had now clotted off.This rn notified [redacted] in charge of babe's care and [redacted] leader of picc team.They attempted to flush picc and were unsuccessful also.At this time, we had to pull the picc.We attempted to place a picc line 3x and were unsuccessful.A scalp piv [peripeheral intravenous line] was placed.

• Brand Name: L-CATHTM PICC S/L
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): ARGON MEDICAL DEVICES, INC.; 1445 flat creek road; athens TX 75751
• MDR Report Key: 23051145
• Report Number: 23051145
• Device Sequence Number: 10038511
• Product Code: LJS
• UDI-Device Identifier: 00886333209910
• UDI-Public: (01)00886333209910
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/06/2025
• Report Date (Section F): 08/06/2025

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
• Device Model Number: 28 GA (1.2F) X 25CM
• Device Catalogue Number: 384516
• Device Lot Number: 11622984
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/15/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/15/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 08/06/2025