MAUDE Adverse Event Report: ARGON MEDICAL DEVICES TLAB TRANSJUGULAR LIVER BIOPSY SYSTEM

Model Number	TL-19
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is unavailable for evaluation.Without such evidence to review, the complaint cannot be confirmed.If additional information is received in the future, a follow-up report will be submitted.
Event or Problem Description
Lot# 1451428 on feb 9th that the sheath around the actual biopsy needle detached from itself.

• Brand Name: TLAB TRANSJUGULAR LIVER BIOPSY SYSTEM
• Common Device Name: TLAB
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX
• MDR Report Key: 11457214
• Report Number: 1625425-2021-00866
• Device Sequence Number: 4088447
• Product Code: DYB
• UDI-Device Identifier: 00886333218516
• UDI-Public: 00886333218516
• Combination Product (Y/N): N
• Initial Reporter State: IL
• PMA/510(K) Number: K022634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/10/2021

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 Expiration Date: 08/05/2023
• Device Model Number: TL-19
• Device Catalogue Number: TL-19
• Device Lot Number: 1451428
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1