MAUDE Adverse Event Report: ARGON MEDICAL DEVICES ACCURA BLN 20G X 7.5CM, WIRE 19.4CM

Model Number	BLN20075
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During use of the bln product, the reinforced part of the hook wire was not fixed and was pushed back and couldn¿t be used (see attached photo), so the surgery was proceeded with another product.
Additional Manufacturer Narrative
Sample is not available for return.An image was provided for investigation.A follow-up report will be submitted upon investigation completion.
Additional Manufacturer Narrative
The portion of the product returned consists of only the cannula.An accurate disposition of what is causing the customer trouble cannot be made having only the cannula and the pictures provided.The problem seems to be with the flexible j-curve wire.Without the wire, a proper investigation could not be executed to determine a root cause.Without a root cause, a corrective action could not be implemented either.If the sample is returned in the future, this investigation will be reopened.
Event or Problem Description
During use of the bln product, the reinforced part of the hook wire was not fixed and was pushed back and couldn¿t be used, so the surgery was proceeded with another product.
Additional Manufacturer Narrative
Udi related data quality updates only.

• Brand Name: ACCURA BLN 20G X 7.5CM, WIRE 19.4CM
• 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: 18253161
• Report Number: 0001417485-2023-00011
• Device Sequence Number: 7108608
• Product Code: GAA
• UDI-Device Identifier: 00886333007493
• UDI-Public: (01)00886333007493(17)280731(10)11478182
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/01/2024

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
• Operator of Device: Health Professional
• Device Model Number: BLN20075
• Device Lot Number: 11478182
• 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: 11/13/2023
• Supplement Date Received by Manufacturer: 11/13/2023; 09/01/2024
• Initial Report FDA Received Date: 12/01/2023
• Supplement Report FDA Received Date: 01/11/2024; 09/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2023
• 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: Other
• Patient Sex: Unknown