MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SKATER CENTESIS CATHETER 5FR X 10CM

Model Number	700305010
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Seems to be drawing air from somewhere, the account believes it is from a very specific spot below the hub.Videos and picture are attached.
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.
Additional Manufacturer Narrative
A review of the manufacturing and inspection records for this lot was conducted, and no deviations and non-conformances were recorded.Customer returned product to argon for investigation.Returned product was visually inspected and a crack/cut was identified on the skater hub.The crack would cause leakage through the skater hub and thus confirmed the complaint.A definitive root cause was not identified.Possible root causes for this event could be the following: 1.Manufacture and/or mishandling by operator.Issues during molding process could cause crack in the hub.2.Issues during assembly, final packaging, shipping, unit storage, mishandling by operator.3.Damaged prior to use after reaching the customer facility.At this time, this is the only confirmed complaint for cracked hub.This issue has been documented and argon will continue to track and monitor this event in the future.
Event or Problem Description
Seems to be drawing air from somewhere, the account believes it is from a very specific spot below the hub.

• Brand Name: SKATER CENTESIS CATHETER 5FR X 10CM
• Common Device Name: SKATER
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: elnaz rahman ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 16963583
• Report Number: 0001625425-2023-01059
• Device Sequence Number: 17452717
• Product Code: GBQ
• UDI-Device Identifier: 00886333005802
• UDI-Public: 00886333005802
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2023

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: 700305010
• Device Catalogue Number: 700305010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/08/2023
• Supplement Date Received by Manufacturer: 05/08/2023
• Initial Report FDA Received Date: 05/19/2023
• Supplement Report FDA Received Date: 06/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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