MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-08 for ACCUVEIN HF470-1 AV 400 manufactured by Accuvein, Inc..
[69364340]
Patient Sequence No: 1, Text Type: N, H10
[69364341]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6386912 |
| MDR Report Key | 6386912 |
| Date Received | 2017-03-08 |
| Date of Report | 2017-02-10 |
| Date of Event | 2017-01-03 |
| Report Date | 2017-02-10 |
| Date Reported to FDA | 2017-02-10 |
| Date Reported to Mfgr | 2017-02-10 |
| Date Added to Maude | 2017-03-08 |
| 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 |
| 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 |
| Brand Name | ACCUVEIN |
| Generic Name | DEVICE, VEIN LOCATION, LIQUID CRYSTAL |
| Product Code | KZA |
| Date Received | 2017-03-08 |
| Model Number | HF470-1 |
| Catalog Number | AV 400 |
| Lot Number | N/A |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 9 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACCUVEIN, INC. |
| Manufacturer Address | 40 GOOSE HILL RD. COLD SPRING HARBOR NY 11724 US 11724 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-08 |