MAUDE Adverse Event Report: ARGON MEDICAL DEVICES HAWKINS II FLEXSTRAND BLN 20GA X 10CM

Model Number	252100
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/03/2021
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
We have several occurrences when using the 10cm needle with wire where we could not remove the needle off of the wire, it gets stuck the radiologist had to pull with a lot f forces to remove it, in a recent procedure it got stuck to the point that they could not remove the needle and sent the patient to surgery with the needle and wire in the breast as far as i know this has not happened with the 5cm or 12.5 needle with wire.
Additional Manufacturer Narrative
A review of the dhr and inspection records was conducted, and although a temporary deviation notice was given, there is no evidence that it contributes to the complaint.It was not necessary to check any other documentation in the course of investigating this complaint.A functional analysis of the returned sample was conducted, and the following findings are relevant to the complaint: the product was not damaged or missing components.Excessive resistance was felt.The returned guidewire was used to pass through the needle of the samples.There was excessive resistance felt as the guidewire moved through the cannula.This is outside of argon specification (needle must be able to pass through the cannula).Therefore, the complaint is confirmed.Since the manufacture of this lot, tdn 120646 was issued to correct the stack up tolerances on our current drawings for the time being.The drawing used (dwg-1280021-x) is currently being updated with the new tolerances to make these changes permanent.
Event or Problem Description
We have several occurrences when using the 10cm needle with wire where we could not remove the needle off of the wire, it gets stuck the radiologist had to pull with a lot f forces to remove it, in a recent procedure it got stuck to the point that they could not remove the needle and sent the patient to surgery with the needle and wire in the breast as far as i know this has not happened with the 5cm or 12.5 needle with wire.
Additional Manufacturer Narrative
The sample is indicated as returned.As of the date of this report, the sample has not been evaluated.A follow-up report will be provided once the device has been reviewed.
Event or Problem Description
We have several occurrences when using the 10cm needle with wire where we could not remove the needle off of the wire, it gets stuck the radiologist had to pull with a lot f forces to remove it, in a recent procedure it got stuck to the point that they could not remove the needle and sent the patient to surgery with the needle and wire in the breast as far as i know this has not happened with the 5cm or 12.5 needle with wire.

• Brand Name: HAWKINS II FLEXSTRAND BLN 20GA X 10CM
• Common Device Name: HAWKINS II FLEXSTRAND BLN
• 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: 13267124
• Report Number: 0001625425-2022-00930
• Device Sequence Number: 20018662
• Product Code: GDM
• UDI-Device Identifier: 00886333003822
• UDI-Public: 00886333003822
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/09/2022

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 Expiration Date: 07/08/2026
• Device Model Number: 252100
• Device Lot Number: 11373483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2022
• 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: 01/07/2022
• Supplement Date Received by Manufacturer: 01/07/2022; 01/07/2022
• Initial Report FDA Received Date: 01/17/2022
• Supplement Report FDA Received Date: 02/21/2022; 03/09/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown