MAUDE Adverse Event Report: ARGON MEDICAL DEVICES HAWKINS II FLEXSTRAND BLN 20GA X 12.5CM; NEEDLE ASPIRATION AND IRRIGATION

Model Number	252125
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Reporter stated "when we park the argon wire in petient & remove the needle in same petient the wire is stuck inside needle & came out the needle.".
Additional Manufacturer Narrative
We have carefully reviewed the manufacturing and inspection records for this lot and found no deviations or non-conformances.Everything meets our high standards of quality.Despite multiple requests, we have not yet received the sample related to the complaint.Additionally, no photographic or visual evidence has been provided to support a review of the concern.Without this necessary information, a thorough investigation cannot be conducted, and identifying a root cause or corrective action is not feasible.At this time, no corrective action is required.However, if the samples are provided at a later date, we would be happy to reopen the complaint for further evaluation.Additional information provided in h6 and h11.

• Brand Name: HAWKINS II FLEXSTRAND BLN 20GA X 12.5CM
• Common Device Name: NEEDLE ASPIRATION AND 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: 22012771
• Report Number: 0001625425-2025-01013
• Device Sequence Number: 17450103
• Product Code: GDM
• UDI-Device Identifier: 00886333003846
• UDI-Public: (01)00886333003846(17)290723(10)11583404
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K870523
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2025

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: 252125
• Device Lot Number: 11583404
• Was Device Available for Evaluation?: Yes
• 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: 04/15/2025
• Supplement Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/07/2024
• 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