MAUDE Adverse Event Report: ARGON MEDICAL DEVICES F8 SKATER DRAIN CATH. STRING; CATHETER, CONTINUOUS IRRIGATION

Model Number	755108025E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Reporter indicated "leak".It was reported that medical intervention was required.
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 manufacturing and inspection records for this lot was conducted.No deviations or non-conformances were found.There were no physical samples returned to argon from the customer however, there was a video provided.Based on the video, it was found that the device exhibited leakage from the string hole.The complaint was confirmed.To address this issue, capa ca-00047 has been initiated.This capa will document the identified root cause and the corrective actions taken to resolve the leakage problem.Additional information provided in h.3., h.6.And h.11.

• Brand Name: F8 SKATER DRAIN CATH. STRING
• Common Device Name: CATHETER, CONTINUOUS IRRIGATION
• 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: 22383536
• Report Number: 0001625425-2025-01049
• Device Sequence Number: 8680417
• Product Code: GBQ
• UDI-Device Identifier: 00886333000159
• UDI-Public: (01)00886333000159(17)280714(10)11483062
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 755108025E
• Device Lot Number: 11483062
• 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: 06/04/2025
• Supplement Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian