MAUDE Adverse Event Report: ARGON MEDICAL DEVICES HAWKINS III FLEXSTRAND BLN 20GA X 5CM

Model Number	253050
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Needle Stick/Puncture (2462); Insufficient Information (4580)
Date of Event	12/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The wire is moving back after being placed for breast needle loc, the wire doesn't appear to be opening up at the end giving it that "v" which holds it in place.
Additional Manufacturer Narrative
Sample is unavailable for evaluation.Without such evident to review, the complaint cannot be confirmed.If additional information is provided in the future, a follow-up report will be submitted.
Additional Manufacturer Narrative
A review of the manufacturing and inspection records for this lot was conducted, and no deviations and non-conformances were recorded.A review of returned product from the customer was performed by visually inspecting the four unopened samples returned from the customer and no damage was found on the product.Customer did not return faulty device to argon for investigation.Returned samples were measured dimensionally and they were all per drawings and specifications.Sample passed smoothly with feel minor interference and all tolerance were in the specification.Sample was tested functionally by passing cannula through needle without interference and hence complaint was not confirmed.No further evaluation or corrective actions are needed at this time.
Event or Problem Description
The wire is moving back after being placed for breast needle loc, the wire doesn't appear to be opening up at the end giving it that "v" which holds it in place.

• Brand Name: HAWKINS III FLEXSTRAND BLN 20GA X 5CM
• Common Device Name: 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: 16134004
• Report Number: 0001625425-2023-00930
• Device Sequence Number: 20713909
• Product Code: GDM
• UDI-Device Identifier: 00886333003860
• UDI-Public: 00886333003860
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Report Date (Section B): 02/09/2023

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
• Device Model Number: 253050
• Device Catalogue Number: 253050
• Device Lot Number: 11438372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 01/03/2023
• Supplement Date Received by Manufacturer: 01/03/2023
• Initial Report FDA Received Date: 01/10/2023
• Supplement Report FDA Received Date: 02/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown