MAUDE Adverse Event Report: VERAN MEDICAL TECHNOLOGIES, INC SPIN XTEND; EXTENDABLE NEEDLE

Model Number INS-5450

Device Problems Detachment of Device or Device Component (2907); Material Protrusion/Extrusion (2979)

Patient Problem Insufficient Information (4580)

Event Date 10/02/2019

Event Type  malfunction  

Event Description

Mdr filed retroactively during a review of current complaints.Metal spring came out of the sheath after second pass.Coil wire appears to be outside of the protective sheath.

• Brand Name: SPIN XTEND
• Type of Device: EXTENDABLE NEEDLE
• Manufacturer (Section D): VERAN MEDICAL TECHNOLOGIES, INC; 1938 innerbelt business center; saint louis MO 63114
• MDR Report Key: 11721778
• MDR Text Key: 250391726
• Report Number: 3007222345-2021-00013
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: INS-5450
• Device Catalogue Number: INS-5450
• Device Lot Number: 03713190304
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1