MAUDE Adverse Event Report: ARGON MEDICAL DEVICES CO-AXIAL INTRODUCER NEEDLE; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Catalog Number

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907); Device Fell (4014)

Patient Problem Insufficient Information (4580)

Event Date 07/06/2021

Event Type  malfunction  

Event Description

Argon supercore biopsy instrument with co-axial introducer needle was being utilized; 18gax9cm instrument with a 17gax3.9cm introducer needle was used and when ready to release the sample.At that time the cocking mechanism was pulled back and then pushed forward and the device fell apart.Tried 2 other devices from same lot number, 1 needle flew out when releasing the sample and landed on floor and the other device fell apart once mechanism was pulled back and pushed forward.Fda safety report id# (b)(4).

• Brand Name: CO-AXIAL INTRODUCER NEEDLE
• Type of Device: NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
• Manufacturer (Section D): ARGON MEDICAL DEVICES
• MDR Report Key: 12159341
• MDR Text Key: 261461935
• Report Number: MW5102460
• Device Sequence Number: 4
• Product Code: GAA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/08/2021
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information

Device Catalogue Number

• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 58 YR