MAUDE Adverse Event Report: ARGON MEDICAL DEVICES, INC BONE MARROW BIOPSY NEEDLE 13GA X 4IN; INSTRUMENT, BIOPSY

Model Number	DBMNJ1304
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/15/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sample is not available for return.The investigation is currently in progress.A follow-up report will be submitted upon investigation completion.
Event or Problem Description
¿patient under anesthesia underwent puncture of the right posterior superior iliac spine, obtaining a small bone sample.A new puncture attempt was made; however, the distal part of the needle fractured.General surgery was called for its extraction.No remnants remained after removal, which was verified by fluoroscopy.¿.

• Brand Name: BONE MARROW BIOPSY NEEDLE 13GA X 4IN
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): ARGON MEDICAL DEVICES, INC; 1445 flat creek road; athens TX 75751
• Manufacturer Contact: kelly mayer ; 1445 flat creek road; athens, TX 75751 ; 9036759321
• MDR Report Key: 25422984
• Report Number: 0001625425-2026-00976
• Device Sequence Number: 14974028
• Product Code: KNW
• UDI-Device Identifier: 00886333001507
• UDI-Public: (01)00886333001507(17)290531(10)11573345
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K980196
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/07/2026

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 Model Number: DBMNJ1304
• Device Lot Number: 11573345
• 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: 05/08/2026
• Initial Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/31/2024
• 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: Required Intervention
• Patient Sex: Unknown