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

Model Number	DBMNJ0804TL
Medical Device Problem Codes	Material Twisted/Bent (2981); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The pinch rod from the bone marrow biopsy pack bent during the procedure inside patient's body.The clinician noticed this when the needle assembly was pulled out after the procedure.The patient was unharmed.
Additional Manufacturer Narrative
According to the product experience report, there was no sample to be returned.Additionally, no photographic or visual evidence of any kind was provided which would have allowed for the allegation to be reviewed.Without such evidence, this complaint could not be confirmed and determining a definite root cause and corrective action is not possible.If the sample is returned at a future date, a follow-up report will be submitted.
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
The pinch rod from the bone marrow biopsy pack bent during the procedure inside patient's body.The clinician noticed this when the needle assembly was pulled out after the procedure.The patient was unharmed.
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.One opened device was returned for evaluation.Visual inspection found the distal end of the trap-lok bent and the complaint was confirmed.Closer inspection found that the tip of the device looked to be cut twice during manufacturing causing the forks to be weaker than normal.The most likely cause of this issue was due to operator/machine error during manufacturing that resulted in the device not being made to specification.The quality manager of the wheeling facility has been made aware of this issue.We are working on a route forward to determine the best way to ensure this issue does not recur.
Event or Problem Description
The pinch rod from the bone marrow biopsy pack bent during the procedure inside patient's body.The clinician noticed this when the needle assembly was pulled out after the procedure.The patient was unharmed.

• 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: 16410280
• Report Number: 0001625425-2023-00971
• Device Sequence Number: 5362836
• Product Code: KNW
• UDI-Device Identifier: 00886333001514
• UDI-Public: 00886333001514
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup
• Report Date (Section B): 04/25/2023
• 2 Devices were Involved in the Event: 1 2

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
• Device Lot Number: 11455470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2023
• Supplement Date Received by Manufacturer: 02/07/2023; 02/07/2023
• Initial Report FDA Received Date: 02/21/2023
• Supplement Report FDA Received Date: 03/22/2023; 04/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/23/2022
• 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