MAUDE Adverse Event Report: ARGON MEDICAL DEVICES BONE MARROW ASPIRATION NEEDLE 16GA X 2.688IN MAX

Model Number	DBMNI1601
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sample in unavailable for evaluation.If additional information is provided in the future, a follow-up report will be submitted.
Event or Problem Description
Bone marrow needle cant handle pressure necessary to penetrate bone, kinks and bends slips away from penetration site does not cut sample property and shatters the bone same as (b)(4).
Event or Problem Description
Bone marrow needle cant handle pressure necessary to penetrate bone, kinks and bends slips away from penetration site does not cut sample property and shatters the bone.Same as (b)(4).
Additional Manufacturer Narrative
A review of the batch records confirmed that the product was manufactured according to specification and no deviations or anomalies were found.According to the per, no device was available to be returned for evaluation.However, an image was provided that showed that a used device was bent and the complaint was confirmed.Without the actual device to evaluate, a definitive root cause evaluation could not be accomplished.Since an evaluation of the device was not performed, no corrective action was taken.

• Brand Name: BONE MARROW ASPIRATION NEEDLE 16GA X 2.688IN MAX
• Common Device Name: BONE MARROW ASPIRATION NEEDLE
• 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: 14549187
• Report Number: 0001625425-2022-01015
• Device Sequence Number: 6502738
• Product Code: KNW
• UDI-Device Identifier: 00886333001446
• UDI-Public: 00886333001446
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2022

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
• Device Expiration Date: 07/07/2026
• Device Model Number: DBMNI1601
• Device Catalogue Number: DBMNI1601
• Device Lot Number: 11375912
• 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: 05/25/2022
• Supplement Date Received by Manufacturer: 05/25/2022
• Initial Report FDA Received Date: 05/31/2022
• Supplement Report FDA Received Date: 07/28/2022
• 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; Required Intervention
• Patient Sex: Unknown