MAUDE Adverse Event Report: ACCUVEIN INC. ACCUVEIN AV400; DEVICE, VEIN LOCATION, LIQUID CRYSTAL

Model Number AV400

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/18/2020

Event Type  malfunction  

Event Description

Our htm (healthcare technology management) received a service call to inspect a broken accuvein finder.The complaint was the "arm is snapped off the machine, wand is working".Technician inspected the device and ordered a replacement arm.Once received, the arm was replaced and device was returned to service.This type of repair has happened numerous occasions and could potentially harm the health care staff member.Manufacturer was made aware when replacement arm was sent out.

• Brand Name: ACCUVEIN AV400
• Type of Device: DEVICE, VEIN LOCATION, LIQUID CRYSTAL
• Manufacturer (Section D): ACCUVEIN INC.; 3243 route 112 building 1, suite 2; medford NY 11763
• MDR Report Key: 10534331
• MDR Text Key: 206964697
• Report Number: 10534331
• Device Sequence Number: 1
• Product Code: KZA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AV400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/11/2020
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1