MAUDE Adverse Event Report: ARGON MEDICAL DEVICES L-CATH PICC D/L BASIC KIT 20GA (2.6F) X 60CM 2 LUMEN); CATHETER INTRAVASCULAR, THERAPEUTIC

Model Number	384566
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Writer notes: 1.2 fr argon picc line inserted by (b)(6) on the 24th at 0230 with ease in right saphenous vein.Noted to be leaking several hours later at the end of the picc where it connects to the straight iv connector.(b)(6) (picc nurse) on and assessed.Changed dressing and line appeared ok.Line then noted to be leaking again a few hours later.(b)(6) advocated that line be removed and team did not want to remove it.Baby had 3 dressing changes before it was removed on the 25th in the afternoon.New picc inserted on 25th after 4 attempts and that line (same lot) is still insitu.Minor harm: minimal symptoms/loss of function/harm.
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.
Additional Manufacturer Narrative
We conducted a thorough review of the manufacturing and inspection records for this lot and found no deviations or non-conformances.No samples were returned from the customer for review.Additionally, no photographic or visual evidence of any kind was provided, which would have allowed the allegation to be reviewed.Without the affected device, a comprehensive investigation cannot be conducted, and a root cause cannot be determined.As a result, no corrective action is required at this point.However, if samples are returned later, we would be happy to reopen this complaint for re-evaluation.Additional information provided in h.6.And h.11.

• Brand Name: L-CATH PICC D/L BASIC KIT 20GA (2.6F) X 60CM 2 LUMEN)
• 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: 24319901
• Report Number: 0001625425-2026-00938
• Device Sequence Number: 21413605
• Product Code: LJS
• UDI-Device Identifier: 00886333209972
• UDI-Public: (01)00886333209972(17)280314(10)11629823
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K230669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2026

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: 384566
• Device Lot Number: 11629823
• Was Device Available for Evaluation?: No
• 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: 01/12/2026
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/21/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown