MAUDE Adverse Event Report: ARGON MEDICAL DEVICES ACCURA BLN 20GA X 5CM

Model Number	BLN2005
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The patient underwent thoracoscopic lung cancer surgery for lung cancer, and the positioning needle under ct is needed before surgery.At the beginning of the operation, if it is found that the positioning needle has been broken, take out the broken puncture needle immediately.
Additional Manufacturer Narrative
The device is not available for return, however, images were provided.Investigation is still ongoing.A follow-up report will be submitted once the investigation is completed.
Additional Manufacturer Narrative
According to the product experience report, there was no sample to be returned.The photo returned with the complaint does show that the needle is separated from the cannula hub.The complaint is confirmed.However, without a physical sample, a more thorough investigation to find a root cause cannot be conducted.
Event or Problem Description
The patient underwent thoracoscopic lung cancer surgery for lung cancer, and the positioning needle under ct is needed before surgery.At the beginning of the operation, if it is found that the positioning needle has been broken, take out the broken puncture needle immediately.

• Brand Name: ACCURA BLN 20GA X 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: 12817100
• Report Number: 0001625425-2021-01123
• Device Sequence Number: 14693138
• Product Code: GAA
• UDI-Device Identifier: 00886333007509
• UDI-Public: 00886333007509
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: 505
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2021

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: 05/07/2025
• Device Model Number: BLN2005
• Device Lot Number: 11308398
• 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: 10/27/2021
• Supplement Date Received by Manufacturer: 10/27/2021
• Initial Report FDA Received Date: 11/15/2021
• Supplement Report FDA Received Date: 12/13/2021
• 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: Other
• Patient Sex: Unknown