MAUDE Adverse Event Report: ARGON MEDICAL DEVICES FIRST PICC S/L 22GA (2.8F) 0.95MM X 50CM

Model Number	384101
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The catheter has a leak in the hose where it drips when infusing liquid.
Additional Manufacturer Narrative
Additional information provided in h.6.And h.11.A review of the dhr and inspection records was conducted, and no similar concerns were found.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, this complaint could not be confirmed.Since there was no sample or visual evidence provided, establishing a root cause for the reported issue is not possible.Since there was no sample or visual evidence provided, establishing a root cause and an appropriate corrective action for the reported issue is not possible.There were two other complaints found in lot.

• Brand Name: FIRST PICC S/L 22GA (2.8F) 0.95MM X 50CM
• Common Device Name: FIRST 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: 20875370
• Report Number: 0001625425-2024-01169
• Device Sequence Number: 21071803
• Product Code: FOZ
• UDI-Device Identifier: 00886333209644
• UDI-Public: (01)00886333209644(17)240707(10)11376562
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K972262
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2025

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 Expiration Date: 07/07/2024
• Device Model Number: 384101
• Device Lot Number: 11376562
• 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: 11/08/2024
• Supplement Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 12/08/2024
• Supplement Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/07/2021
• 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