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)
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
Customer reports that they are still seeing some leaking from l-caths.They tried switching from icu medical extension sets to b-braun ext sets but they are still seeing minor leaking.They say it has been very inconsistent.They currently have no affected product available for return.Worth noting that this is a very experienced picc team.
Additional Manufacturer Narrative
We were unable to review the manufacturing and inspection records as the lot # was missing.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 necessary evidence, we are unable to perform a thorough investigation or determine a root cause and corrective action currently.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 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: kelly mayer ; 1445 flat creek road; athens, TX 75751 ; 9036759321
• MDR Report Key: 22786696
• Report Number: 0001625425-2025-01065
• Device Sequence Number: 10045832
• Product Code: LJS
• UDI-Device Identifier: 00886333209910
• UDI-Public: 00886333209910
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K091670
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2026

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: 384516
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2025
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown