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

Model Number	DBMNJ0804TL
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The access device does not allow for the trap piece to be inserted with ease (resistance can be felt) and it creates a more narrow end at the point where the core biopsy sample would be obtained.Because of this, the core sample has not been as long/adequate as normal and the nurses are having to insert the trap multiple times to get enough of a sample.The needle is smaller in this lot than what it should be, it takes multiple passes to get what is needed.The needle is smaller in this lot than what it should be, it takes multiple passes to get what is needed.
Additional Manufacturer Narrative
The sample is indicated as available for return.As of the date of this report, the sample has not been returned.A follow-up report will be provided once the device has been received and reviewed.
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.After three notifications, the sample from the alleged complaint has not returned.Additionally, no photographic or visual evidence of any kind was provided which would have allowed for the allegation to be reviewed.Without a device 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
The access device does not allow for the trap piece to be inserted with ease (resistance can be felt) and it creates a more narrow end at the point where the core biopsy sample would be obtained.Because of this, the core sample has not been as long/adequate as normal and the nurses are having to insert the trap multiple times to get enough of a sample.The needle is smaller in this lot than what it should be, it takes multiple passes to get what is needed.The needle is smaller in this lot than what it should be, it takes multiple passes to get what is needed.

• 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: 15190903
• Report Number: 0001625425-2022-01055
• Device Sequence Number: 20336932
• Product Code: KNW
• UDI-Device Identifier: 00886333001514
• UDI-Public: 00886333001514
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Other
• 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
• Device Lot Number: 11427645
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2022
• Supplement Date Received by Manufacturer: 08/02/2022
• Initial Report FDA Received Date: 08/09/2022
• Supplement Report FDA Received Date: 10/03/2022
• 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: Required Intervention; Other
• Patient Sex: Unknown