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

Model Number HF470

Device Problem Component Missing (2306)

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

Event Date 09/21/2017

Event Type  malfunction  

Event Description

In the past someone had stolen the accuvein from the accuvein cart so we bought a new one and placed a screw on it to keep the accuvein in place.Today we noticed the screw was gone.We contacted accuvein for a security screw and they do not offer one.In my opinion they should offer this screw for their equipment and not only should they offer it but it should be provided as part of the initial purchase.Manufacturer response: for accuvein cart, accuvein (per site reporter).They said just put a screw in it.

• Brand Name: ACCUVEIN
• Type of Device: DEVICE, VEIN LOCATION, LIQUID CRYSTAL
• Manufacturer (Section D): ACCUVEIN INC.; 400 goose hill road; cold springs harbor NY 11724
• MDR Report Key: 6951515
• MDR Text Key: 89409440
• Report Number: 6951515
• Device Sequence Number: 1
• Product Code: KZA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• 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: 09/21/2017
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/21/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO