ACCUVEIN HF470

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-16 for ACCUVEIN HF470 manufactured by Accuvein Inc..

Event Text Entries

[89409439]
Patient Sequence No: 1, Text Type: N, H10

[89409440] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 6951515
• MDR Report Key: 6951515
• Date Received: 2017-10-16
• Date of Report: 2017-09-21
• Date of Event: 2017-09-21
• Report Date: 2017-09-21
• Date Reported to FDA: 2017-09-21
• Date Reported to Mfgr: 2017-09-21
• Date Added to Maude: 2017-10-16
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: BIOMEDICAL ENGINEER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ACCUVEIN
• Generic Name: DEVICE, VEIN LOCATION, LIQUID CRYSTAL
• Product Code: KZA
• Date Received: 2017-10-16
• Model Number: HF470
• Catalog Number: HF470
• Device Availability: Y
• Device Age: 1 YR
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ACCUVEIN INC.
• Manufacturer Address: 400 GOOSE HILL ROAD COLD SPRINGS HARBOR NY 11724 US 11724

Patients

Patient Number	Treatment	Outcome	Date
1	0		2017-10-16