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

Model Number	DBMNJ0804TL
Medical Device Problem Code	Failure to Obtain Sample (2533)
Health Effect - Clinical Codes	Distress (2329); Discomfort (2330)
Date of Event	10/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
When carrying out an osteomedullary biopsy on (b)(6) 2023, failure to collect the medullary core by the extraction cannula which is not waterproof and does not allow the sample to be maintained to recover it at the exit of the cannula.Collection of the biopsy sample after diversion maneuver which is at risk of hemorrhage.This event was a source of stress for the patient and caused an organizational dysfunction with an extension of the duration of hospitalization of the patient in day hospital.To compensate for the incident, it was necessary to apply several pressure dressings and to reinforce clinical monitoring.
Additional Manufacturer Narrative
Sample is not available for return.Argon is actively investigating this event.A follow-up report will be submitted upon investigation completion.
Additional Manufacturer Narrative
A review of the manufacturing and inspection records for this lot number was conducted.There were no deviations or non conformances noted.The customer has stated that no sample is available to return for evaluation.Additionally, no photographic or visual evidence of any kind was provided which would have allowed for determination of cause for failure and necessary corrective action.If the sample is returned at a future date, this complaint may be reopened for further evaluation at that time.
Event or Problem Description
When carrying out an osteomedullary biopsy on (b)(6) 2023, failure to collect the medullary core by the extraction cannula which is not waterproof and does not allow the sample to be maintained to recover it at the exit of the cannula.Collection of the biopsy sample after diversion maneuver which is at risk of hemorrhage.This event was a source of stress for the patient and caused an organizational dysfunction with an extension of the duration of hospitalization of the patient in day hospital.To compensate for the incident, it was necessary to apply several pressure dressings and to reinforce clinical monitoring.
Additional Manufacturer Narrative
Udi related data quality updates only.

• 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: 17950827
• Report Number: 0001417485-2023-00008
• Device Sequence Number: 15153445
• Product Code: KNW
• UDI-Device Identifier: 00886333001514
• UDI-Public: (01)00886333001514(17)271212(10)11453365
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/01/2024

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 Lot Number: 11453365
• 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: 10/11/2023
• Supplement Date Received by Manufacturer: 10/11/2023; 09/01/2024
• Initial Report FDA Received Date: 10/17/2023
• Supplement Report FDA Received Date: 11/29/2023; 09/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2022
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown