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

Model Number	384516
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
¿the catheter in particular we have experienced this with is the l-cath 28g introducer/ 1.2 single lumen picc line." ¿at times we are concerned that the hub on the picc line is cracked which has caused leaking; also, at times the tubing we typically use for picc line extension has been leaking once we hook it up to the picc line (as soon as we use our normal piv tubing the leaking stops).It has happened enough times that i wanted to reach out and see if you had any suggestions for us in regard to this particular line leaking and site care.¿.
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.Unfortunately, we did not receive any samples for evaluation, nor did we receive any photographic or visual evidence that would have allowed us to review the allegation in detail.Without this necessary evidence, we are unable to perform a thorough investigation or determine a root cause and corrective action at this time.As a result, no corrective action is required at this point.However, if samples are returned at a later date, we would be happy to reopen this complaint for re-evaluation.Argon's sustaining engineering team is aware of this complaint and is currently investigating the root cause.Additional information provided in h.6.And h.11.

• Brand Name: L-CATH PICC S/L 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: 22009987
• Report Number: 0001625425-2025-01010
• Device Sequence Number: 18102286
• Product Code: LJS
• UDI-Device Identifier: 00886333209910
• UDI-Public: (01)00886333209910(17)271001(10)11600231
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2025

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
• Operator of Device: Health Professional
• Device Model Number: 384516
• Device Lot Number: 11600231
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/19/2024
• 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
• Patient Sex: Unknown