MAUDE Adverse Event Report: ARGON MEDICAL DEVICES L-CATH PICC S/L BASIC KIT 28GA (1.2F) X 25CM 1 LUMEN; CATHETER INTRAVASCULAR, THERAPEUTIC

Model Number	384516
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A nurse reported that during assessment a patients peripherally inserted central catheter (picc) line dressing noted to be saturated with fluid and lifting.Upon closer inspection fluid leaking at connection between picc line hub and extension tubing.Tubing adequately tightened.The tubing was changed to try and resolve issue but persistently leaking when flushed with ns and slowly beading and dripping from hub.Hub of picc line noted to not be perfectly round but more oval shaped.Date implanted: (b)(6) 2025.Would need to replace picc line to fully rectify issue.Level of effect: temporary harm - fluids were not being infused as ordered.It is unknown if the picc line was replaced.The sample is not available for return.
Additional Manufacturer Narrative
The sample is not available for return.The investigation is currently in progress.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 by the customer for evaluation.Additionally, the photographic evidence provided by the customer appeared to support the reported allegation.However, without access to the device affected, we are unable to complete a thorough investigation.As a result, we cannot determine a definitive root cause or establish an appropriate corrective action at this time.Additional information provided in h.6.And h.11.

• Brand Name: L-CATH PICC S/L BASIC KIT 28GA (1.2F) X 25CM 1 LUMEN
• Common Device Name: CATHETER INTRAVASCULAR, THERAPEUTIC
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek road; athens TX 75751
• Manufacturer Contact: argon devices ; 1445 flat creek road; athens, TX 75751 ; 9036759321
• MDR Report Key: 23619203
• Report Number: 0001625425-2025-01133
• Device Sequence Number: 21100361
• Product Code: LJS
• UDI-Device Identifier: 00886333209910
• UDI-Public: (01)00886333209910(17)280310(10)11626935
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K091670
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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: 384516
• Device Lot Number: 11626935
• 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: 10/22/2025
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/18/2025
• 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: Other
• Patient Sex: Unknown