ACCUVEIN HF470 HF470-1

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-30 for ACCUVEIN HF470 HF470-1 manufactured by Accuvein.

Event Text Entries

[98933891] The accuvein hf470 hands-free rolling stand for the accuvein av400 regularly breaks at the proximal end of the extension arm. The arm completely breaks off the stand. The breaks occur in use and during transport. We believe one of the factors to the breaks is that the end user has to apply regular downward force to lock the arm in an arm-lock mechanism that is located close to the break. This regular stress causes a small crack to appear with regular use, which then grows, and eventually results in a complete break. Sometimes the break occurs internally without the arm breaking completely off, which damages a power cord and prevents the av400 from charging while in the stand. Unfortunately, we do not have good solid numbers on the number of broken stands b/c we do not track these stands the same way as the medical device that attaches to the stand. We know how many av400s we have, but not exactly how many stands (they don't all have stands). However, out of the 20-30 stands we have in place, we believe roughly 10 have broken in the past 2 years.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5074984
• MDR Report Key: 7230566
• Date Received: 2018-01-30
• Date of Report: 2018-01-29
• Date Added to Maude: 2018-01-31
• Event Key: 0
• Report Source Code: Voluntary 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: OTHER HEALTH CARE PROFESSIONAL
• 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: 0

Device Sequence Number: 1

• Brand Name: ACCUVEIN
• Generic Name: ACCUVEIN
• Product Code: KZA
• Date Received: 2018-01-30
• Model Number: HF470
• Catalog Number: HF470-1
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ACCUVEIN
• Manufacturer Address: HUNTINGTON NY 11743 US 11743

Device Sequence Number: 2

• Brand Name: ACCUVEIN
• Generic Name: ACCUVEIN
• Product Code: KZA
• Date Received: 2018-01-30
• Model Number: HF470
• Catalog Number: HF470-1
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: ACCUVEIN
• Manufacturer Address: HUNTINGTON NY 11743 US 11743

Device Sequence Number: 3

• Brand Name: ACCUVEIN
• Generic Name: ACCUVEIN
• Product Code: KZA
• Date Received: 2018-01-30
• Model Number: HF470
• Catalog Number: HF470-1
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: ACCUVEIN
• Manufacturer Address: HUNTINGTON NY 11743 US 11743

Device Sequence Number: 4

• Brand Name: ACCUVEIN
• Generic Name: ACCUVEIN
• Product Code: KZA
• Date Received: 2018-01-30
• Model Number: HF470
• Catalog Number: HF470-1
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 4
• Device Event Key: 0
• Manufacturer: ACCUVEIN
• Manufacturer Address: HUNTINGTON NY 11743 US 11743

Device Sequence Number: 5

• Brand Name: ACCUVEIN
• Generic Name: ACCUVEIN
• Product Code: KZA
• Date Received: 2018-01-30
• Model Number: HF470
• Catalog Number: HF470-1
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 5
• Device Event Key: 0
• Manufacturer: ACCUVEIN
• Manufacturer Address: HUNTINGTON NY 11743 US 11743

Device Sequence Number: 6

• Brand Name: ACCUVEIN
• Generic Name: ACCUVEIN
• Product Code: KZA
• Date Received: 2018-01-30
• Model Number: HF470
• Catalog Number: HF470-1
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 6
• Device Event Key: 0
• Manufacturer: ACCUVEIN
• Manufacturer Address: HUNTINGTON NY 11743 US 11743

Device Sequence Number: 7

• Brand Name: ACCUVEIN
• Generic Name: ACCUVEIN
• Product Code: KZA
• Date Received: 2018-01-30
• Model Number: HF470
• Catalog Number: HF470-1
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 7
• Device Event Key: 0
• Manufacturer: ACCUVEIN
• Manufacturer Address: HUNTINGTON NY 11743 US 11743

Device Sequence Number: 8

• Brand Name: ACCUVEIN
• Generic Name: ACCUVEIN
• Product Code: KZA
• Date Received: 2018-01-30
• Model Number: HF470
• Catalog Number: HF470-1
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 8
• Device Event Key: 0
• Manufacturer: ACCUVEIN
• Manufacturer Address: HUNTINGTON NY 11743 US 11743

Device Sequence Number: 9

• Brand Name: ACCUVEIN
• Generic Name: ACCUVEIN
• Product Code: KZA
• Date Received: 2018-01-30
• Model Number: HF470
• Catalog Number: HF470-1
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 9
• Device Event Key: 0
• Manufacturer: ACCUVEIN
• Manufacturer Address: HUNTINGTON NY 11743 US 11743

Device Sequence Number: 10

• Brand Name: ACCUVEIN
• Generic Name: ACCUVEIN
• Product Code: KZA
• Date Received: 2018-01-30
• Model Number: HF470
• Catalog Number: HF470-1
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 10
• Device Event Key: 0
• Manufacturer: ACCUVEIN
• Manufacturer Address: HUNTINGTON NY 11743 US 11743

Patients

Patient Number	Treatment	Outcome	Date
1	0		2018-01-30