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 Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2023
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.
Additional Manufacturer Narrative
The sample is not available for return.Reporter provided videos for investigation.A follow-up report will be submitted once the videos are reviewed.
Additional Manufacturer Narrative
A review of the manufacturing and inspection records for this lot number was conducted.There were no deviations or non-conformances recorded.A review of the photos and video provided by the customer was completed.The first video was reviewed, and air was found in the extension line, while in the second video, air was found in the extension tube.While in the other videos there is no identification of any leakage in the skater centesis catheter.Based on the videos provided by customer, the product complaint mode cannot be duplicated.Therefore, the complaint was not confirmed further evaluation is not needed at this time.No corrective actions were initiated either.A follow-up report will be submitted if new information becomes available.
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.

• 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: 16902469
• Report Number: 0001625425-2023-01043
• Device Sequence Number: 6847671
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2023

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
• Device Lot Number: 11471542
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2023
• Supplement Date Received by Manufacturer: 04/26/2023
• Initial Report FDA Received Date: 05/10/2023
• Supplement Report FDA Received Date: 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2023
• 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: Other
• Patient Sex: Unknown