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

Model Number HF470-1

Device Problems Break (1069); Crack (1135); Device Dislodged or Dislocated (2923)

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

Event Date 01/03/2017

Event Type  malfunction  

Event Description

The accuvein is composed of two major pieces: unit and the roll-stand.The stands are falling apart and continue to fail on regular basis at an unacceptable high rate.Once the stand breaks, it causes the main unit to dislodge and potentially fall and gets cracked and fall apart.Currently we have in our biomed workshop about 5 broken stands with at least 3 broken units.The rate of these units being broken is affecting the hospital's ability to provide proper and timely care to our patients, those who need the accuvien for care.Manufacturer response for vein finder, accuvein (per site reporter): we met with the manufacturer more than once, we discussed our concerns and we showed them what is happening.This has been going on for more than a year.The manufacturer reported that the units are breaking because the hospital uses bleach to contain cross contamination and reduce hospital associated infections (hais).The hospital reviewed that comment, and we found out that even the containers used to hold the cleaning products is made of plastic material that does not fail or crack even when left for months and months with the solution in it.Now, the only option for the hospital to get the devices repaired and working, is: - send the broken unit back to oem and get replacement for (b)(4) each with 90 days warranty, and (b)(4) with a 1 year warranty.Anyhow, warranty does not cover broken units/stands, and they do not consider what we are experiencing as manufacturer defect.- send the stands back to the oem and get a replacement for (b)(4) for a refurbished stand and (b)(4) for a new one.- sign a contractual agreement that will cover the units and the stand, but we still pay a copay for the stand, even with the highest tier agreement level.Bottom line, we are expected to pay not less than (b)(4) per each unit, for multiple units, multiple times a year.With the oem still considering the failures we have are not ordinary, with no serious steps to resolve.

Manufacturer Narrative

Unique device identifier (udi): for type of device: device, vein location, liquid crystal.

Event Description

The accuvein is composed of two major pieces: unit and the roll-stand.The stands are falling apart and continue to fail on regular basis at an unacceptable high rate.Once the stand breaks, it causes the main unit to dislodge and potentially fall and gets cracked and fall apart.Currently we have in our biomed workshop about 5 broken stands with at least 3 broken units.The rate of these units being broken is affecting the hospital's ability to provide proper and timely care to our patients, those who need the accuvien for care.Manufacturer response for vein finder, accuvein (per site reporter): we met with the manufacturer more than once, we discussed our concerns and we showed them what is happening.This has been going on for more than a year.The manufacturer reported that the units are breaking because the hospital uses bleach to contain cross contamination and reduce hospital associated infections (hais).The hospital reviewed that comment, and we found out that even the containers used to hold the cleaning products is made of plastic material that does not fail or crack even when left for months and months with the solution in it.Now, the only option for the hospital to get the devices repaired and working, is: send the broken unit back to oem and get replacement for (b)(6) each with 90 days warranty, and (b)(6) with a 1 year warranty.Anyhow, warranty does not cover broken units/stands, and they do not consider what we are experiencing as manufacturer defect.Send the stands back to the oem and get a replacement for (b)(6) for a refurbished stand and (b)(6) for a new one.Sign a contractual agreement that will cover the units and the stand, but we still pay a copay for the stand, even with the highest tier agreement level.Bottom line, we are expected to pay not less than (b)(6) per each unit, for multiple units, multiple times a year.With the oem still considering the failures we have are not ordinary, with no serious steps to resolve.

• Brand Name: ACCUVEIN
• Type of Device: DEVICE, VEIN LOCATION, LIQUID CRYSTAL
• Manufacturer (Section D): ACCUVEIN, INC.; 40 goose hill rd.; cold spring harbor NY 11724
• MDR Report Key: 6386912
• MDR Text Key: 69364341
• Report Number: 6386912
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 02/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: HF470-1
• Device Catalogue Number: AV 400
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/10/2017
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1