MAUDE Adverse Event Report: ARGON MEDICAL DEVICES BONE MARROW HARVEST NEEDLE

Model Number	BMHN1104VX
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
35 samples were returned and reviewed.5 sealed samples and 1 opened sample were returned for lot 11267856.9 sealed samples were returned for lot 11226967.3 sealed samples were returned for lot 11294492.1 sealed sample was returned for lot 11269277.17 sealed samples were returned for lot 11232375.All of the products were opened and examined for visual inspection, no damage was observed.1 sample from each returned lot was functionally tested by collecting samples from a bar of soap.Each device successfully captured a sample, the complaint could not be confirmed.Since the failure mode could not be duplicated, no further root cause analysis is required at this time.
Event or Problem Description
Physician statement: after the initial insertion of the harvest needle into the patient (hard bone), the stylet was removed, and aspiration was successful.The stylet was reinserted, and the needle was advanced with second aspiration.The process was repeated again.After the third aspirate, the stylet was again reinserted, and needle entirely removed.Prior to reinsertion for the second puncture of the procedure, the physician noticed the shortened sheath.

• Brand Name: BONE MARROW HARVEST NEEDLE
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX
• MDR Report Key: 10611441
• Report Number: 1625425-2020-00545
• Device Sequence Number: 19804781
• Product Code: KNW
• UDI-Device Identifier: 00886333007660
• UDI-Public: 00886333007660
• Combination Product (Y/N): N
• Initial Reporter State: KS
• PMA/510(K) Number: K980196
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/30/2020

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: BMHN1104VX
• Device Catalogue Number: BMHN1104VX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/01/2020
• 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