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

Model Number	384516
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is indicated as available for return.As of the date of this report, the sample has not been returned.A follow-up report will be provided once the device has been received and reviewed.
Event or Problem Description
Reporter indicated shortly after successful placement noticed the dressing was saturated.Upon inspection, the hub did not appear to be cracked so they changed the extension set and dressing.After a time noticed the dressing was again wet (to the point of sliding).Inspected the hub and again, didn¿t appear to be cracked.Changed the extension set again.Eventually switched to a needless connector that appeared to be working as of the morning of 12/9/24.Piccs are still in-dwelling (will be saved to send in when lines are pulled) as of now.They switched to putting in their backup footprint 28g and noted that they have had no issues with the same extension sets.Was also noted that seemed to be fine with 1-2ml/hr flow, but when flow was increased to 17ml/hr leaking occurred.
Additional Manufacturer Narrative
A review of the dhr and inspection records was conducted, and no similar concerns were found.After three notifications, there has been no sample returned for review.Additionally, there was no visual evidence provided to support the alleged complaint.Without such evidence, the results are inconclusive and therefore, this complaint could not be confirmed.Establishing a root cause and an appropriate corrective action for the reported issue is not possible without the sample to investigate.If the sample is returned at a future date, this complaint may be reopened for further evaluation at that time.

• Brand Name: L-CATH PICC S/L BASIC KIT 28GA (1.2F) X 25CM 1 LUMEN)
• Common Device Name: L-CATH PICC
• 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: 21248062
• Report Number: 0001625425-2025-00927
• Device Sequence Number: 15566097
• Product Code: LJS
• UDI-Device Identifier: 00886333209910
• UDI-Public: (01)00886333209910(17)270910(10)11589349
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2025

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: 11589349
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2024
• Supplement Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 01/27/2025
• Supplement Report FDA Received Date: 04/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/13/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ICU 7 SMALLBORE EXT SET W/ REMV CLAVE; ICU MEDICAL MICROBORE EXTENSION SET; ICU MEDICAL SMALLBORE EXT SET W/CLAMP
• Patient Sex: Unknown