MAUDE Adverse Event Report: ARGON MEDICAL DEVICES ACCURA BLN 20GA X 7.5CM

Model Number	BLN20075
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/08/2019
Type of Reportable Event	Malfunction
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.
Event or Problem Description
On (b)(6) 2019, the patient underwent percutaneous puncture and localization of left breast mass with a positioning needle under ultrasound guidance.The purpose of use is to locate breast nodules.The residual metal foreign body found in the re-examination is suspected to be part of the structure of the positioning needle.The patient was operated on and removed.

• Brand Name: ACCURA BLN 20GA X 7.5CM
• Common Device Name: ACCURA 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: 14139500
• Report Number: 0001625425-2022-00982
• Device Sequence Number: 4793363
• Product Code: GAA
• UDI-Device Identifier: 00886333007493
• UDI-Public: 00886333007493
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K974741
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/18/2022

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 Expiration Date: 03/26/2024
• Device Model Number: BLN20075
• Device Lot Number: 11250952
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 04/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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