MAUDE Adverse Event Report: ARGON MEDICAL DEVICES T-LOK BONE MARROW BIOPSY NEEDLE 8GA X 4IN

Model Number	DBMNJ0804TL
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is indicated as returned.As of the date of this report, the sample has not been evaluated.A follow-up report will be provided once the device has been reviewed.
Event or Problem Description
"practitioner was performing bone marrow biopsy as per normal.When she pulled out the biopsy needle and removed the cannula and attempted to push out core biopsy, there was a long piece of metal that came out.No biopsy specimen present.Appears that it came from inside the needle itself.She performed the procedure with another needle successfully.".
Additional Manufacturer Narrative
A lot number was not provided, so a batch record review could not be conducted.One opened device was returned for evaluation.Visual inspection found that the trap loc cannula was kinked in two places.All other components were not damaged and found to be manufactured to argon specification.The kinks were straightened out and the obturator was inserted to check for additional metal debris.None was found.The metal piece was not returned for evaluation.Without product to evaluate, determining root cause or corrective action is not possible.If the sample is returned at a future date, this complaint may be reopened for further evaluation at that time.
Event or Problem Description
"practitioner was performing bone marrow biopsy as per normal.When she pulled out the biopsy needle and removed the cannula and attempted to push out core biopsy, there was a long piece of metal that came out.No biopsy specimen present.Appears that it came from inside the needle itself.She performed the procedure with another needle successfully.".

• Brand Name: T-LOK BONE MARROW BIOPSY NEEDLE 8GA X 4IN
• Common Device Name: T-LOK BONE MARROW BIOPSY 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: 15445833
• Report Number: 0001625425-2022-01089
• Device Sequence Number: 17343400
• Product Code: KNW
• UDI-Device Identifier: 00886333001514
• UDI-Public: 00886333001514
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: DBMNJ0804TL
• Device Catalogue Number: DBMNJ0804TL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2022
• 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: 09/01/2022
• Supplement Date Received by Manufacturer: 09/01/2022
• Initial Report FDA Received Date: 09/19/2022
• Supplement Report FDA Received Date: 10/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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