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

Model Number HF470

Device Problems Break (1069); Positioning Failure (1158); Structural Problem (2506)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/27/2018

Event Type  malfunction  

Event Description

There are several weak points in this roll stand arm system where it can and has broke at different pivot points.This is a design failure issue.There is also a stopper in place so that the arm will not turn 360 degrees, but that stopper has broken in the past and caused the wiring to rip.Manufacturer response for roll stand, accuvein (per site reporter).They just offer to sell us a replacement as they consider these types of failures user abuse issues.

• Brand Name: ACCUVEIN
• Type of Device: DEVICE, VEIN LOCATION, LIQUID CRYSTAL
• Manufacturer (Section D): ACCUVEIN INC; 40 goose hill road; cold spring harbor NY 11724
• MDR Report Key: 7825999
• MDR Text Key: 118554877
• Report Number: 7825999
• 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: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HF470
• Device Catalogue Number: HF470
• 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: 08/27/2018
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1