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

Model Number	765014100
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation of Vessels (2135)
Date of Event	10/12/2022
Type of Reportable Event	Serious Injury
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
It took more than one shot to harvest a fragment.With the last patient, the cutting blade (which was open) caused injury to small vessels and bleeding.This has caused some inconvenience to my medical team.Note: this is the doctor's second complaint with a different batch.Previous complaint no.(b)(4).

• Brand Name: PRO-MAG BIOPSY NEEDLE 14GA X 10CM
• Common Device Name: PRO-MAG BIOPSY
• 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: 16187183
• Report Number: 0001625425-2023-00937
• Device Sequence Number: 14095996
• Product Code: KNW
• UDI-Device Identifier: 00886333006861
• UDI-Public: 00886333006861
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/17/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 765014100
• Device Catalogue Number: 765014100
• Device Lot Number: 11409806
• Was Device Available for Evaluation?: No
• 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: 01/09/2023
• Initial Report FDA Received Date: 01/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2022
• 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