MAUDE Adverse Event Report: ARGON MEDICAL DEVICES PRO-MAG BIOPSY NEEDLE 14GA X 10CM

Model Number	765014100
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Dr.(b)(6) peres mastologist reported what happened during the patient's breast biopsy, the needle bent after firing the pro-mag pistol and causing abnormal bleeding.The physician was scared, as this had never happened before.
Additional Manufacturer Narrative
A review of the manufacturing and inspection records for this lot was conducted, and no deviations and non-conformances were recorded.According to the product experience report, there was no sample to be returned.An images of the needle was provided by the customer confirming that the needle had bent.However, without the sample for investigation, a definite root cause cannot be identified and hence no corrective action can be implemented either.If new information becomes available in future a follow-up report will be submitted accordingly.
Additional Manufacturer Narrative
Udi related data quality updates only.

• Brand Name: PRO-MAG BIOPSY NEEDLE 14GA X 10CM
• Common Device Name: PRO-MAG
• 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: 18253127
• Report Number: 0001417485-2023-00010
• Device Sequence Number: 12527647
• Product Code: KNW
• UDI-Device Identifier: 00886333006861
• UDI-Public: (01)00886333006861(17)280101(10)11461566
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K980226
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: 765014100
• Device Lot Number: 11461566
• 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: 11/08/2023
• Supplement Date Received by Manufacturer: 08/31/2024
• Initial Report FDA Received Date: 12/01/2023
• Supplement Report FDA Received Date: 08/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2023
• 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