MAUDE Adverse Event Report: VERAN MEDICAL TECHNOLOGIES INC. ALWAYS-ON TIP TRACKED 22GA ANSO FLEXIBLE NEEDLE; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number INS-5410

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 11/11/2020

Event Type  malfunction  

Event Description

Veran needle malfunctioned during use.Patient was not harmed.Device representative was present and notified by the surgeon.The device was brought to materials manager with the patient information.

• Brand Name: ALWAYS-ON TIP TRACKED 22GA ANSO FLEXIBLE NEEDLE
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): VERAN MEDICAL TECHNOLOGIES INC.; 1908 innerbelt business center dr; saint louis MO 63114
• MDR Report Key: 10874880
• MDR Text Key: 217328476
• Report Number: 10874880
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: INS-5410
• Device Catalogue Number: INS-5410
• Device Lot Number: 04452200423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/17/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24455 DA