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

Model Number	BLN20075
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
After the procedure, they found that the hard wire part was pushed back as attached pic.And we were asked by the hospital to check with the manufacturer.
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
After the procedure, they found that the hard wire part was pushed back as attached pic.And we were asked by the hospital to check with the manufacturer.
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.According to the product experience report, there was no sample to be returned.A photo was returned with the complaint, however, the photo does not provide evidence of any manufacturing defect; the photo is suggestive of damage in the user environment.Without such evidence, this complaint could not be confirmed and determining a definite root cause and corrective action is not possible.

• 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: 13192610
• Report Number: 0001625425-2022-00918
• Device Sequence Number: 5199365
• Product Code: GAA
• UDI-Device Identifier: 00886333007493
• UDI-Public: 00886333007493
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/23/2026
• Device Model Number: BLN20075
• Device Lot Number: 11372244
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2022
• Supplement Date Received by Manufacturer: 01/04/2022
• Initial Report FDA Received Date: 01/07/2022
• Supplement Report FDA Received Date: 02/28/2022
• 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: Other
• Patient Sex: Unknown