MAUDE Adverse Event Report: VERAN MEDICAL TECHNOLOGIES VERAN ALWAYS-ON TIP TRACKED 22GA SPIN FLEX NEEDLE; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number INS-5410

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 05/08/2023

Event Type  Injury  

Event Description

Recoil did not work on both products of the same lot number.Reference report: mw5118750.

• Brand Name: VERAN ALWAYS-ON TIP TRACKED 22GA SPIN FLEX NEEDLE
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): VERAN MEDICAL TECHNOLOGIES; st. louis MO
• MDR Report Key: 17198231
• MDR Text Key: 317947083
• Report Number: MW5118749
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• 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: 06/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: INS-5410
• Device Catalogue Number: INS-5410
• Device Lot Number: 06332230201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 62 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White