MAUDE Adverse Event Report: ARGON MEDICAL DEVICES L-CATH MIDLINE S/L CATHETER KIT 20GA (3F) X 20CM

Model Number	384631
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The midline came apart from the hub.Noticed after dressing was completely saturated.
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
A review of the dhr and inspection records could not be conducted, since a lot number was not provided.According to the customer, there were no samples available for review.Additionally, there was no visual evidence provided to support the alleged complaint.Without such evidence, the results are inconclusive, and the complaint could not be confirmed.Establishing a root cause and appropriate corrective action for the reported issue is not possible.Additional information was provided in h.6.And h.11.

• Brand Name: L-CATH MIDLINE S/L CATHETER KIT 20GA (3F) X 20CM
• Common Device Name: L-CATH MIDLINE
• 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: 21055321
• Report Number: 0001625425-2025-00917
• Device Sequence Number: 8067626
• Product Code: FOZ
• UDI-Device Identifier: 00886333210022
• UDI-Public: 00886333210022
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 04/01/2025

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: 384631
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2024
• Supplement Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 04/01/2025
• 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