MAUDE Adverse Event Report: ARGON MEDICAL DEVICES F8 SKATER DRAIN CATH. STRING

Model Number	755108035E
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A reporter indicated there was leakage from the hub after finished case.The treatment process was completed, but the area where the thread came out leaked, so had to re-treat it with a different product.
Additional Manufacturer Narrative
The product was returned for analysis.Investigation including root cause analysis is in progress.A supplemental mdr 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.One opened sample was returned from the customer for review.A visual inspection and testing were performed on the returned product.The device was tested with argon manufactured syringe for leakage and it was observed that there was leakage from the string hole.An internal investigation has been initiated to address the leakage issue.
Additional Manufacturer Narrative
Udi related data quality updates only.

• Brand Name: F8 SKATER DRAIN CATH. STRING
• Common Device Name: SKATER
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: kelly mayer ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 19087657
• Report Number: 0001625425-2024-00980
• Device Sequence Number: 20757953
• Product Code: GBQ
• UDI-Device Identifier: 00886333000166
• UDI-Public: (01)00886333000166(17)271122(10)11451034
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/04/2024

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: 755108035E
• Device Lot Number: 11451034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2024
• Supplement Date Received by Manufacturer: 04/11/2024; 05/15/2024; 09/04/2024
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 04/11/2024; 06/14/2024; 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2022
• 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: Other
• Patient Sex: Unknown