MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-01-14 for VENOUS WINDOW NEEDLE GUIDE (V-WING) 7 MM, DEPTH 8MM 0071 manufactured by Vital Access Corporation.
[4201359]
Pt complained of difficulty with cannulation with venous window needle guide also known as v-wing device. She has not been using v-wing for cannulation of the fistula for purpose of hemodialysis since (b)(4) 2013. Additionally, there was a complaint of pain on cannulation through the device and difficulty to obtain adequate blood return through v-wing site. Distal v-wing site problems were worse than the proximal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3653225 |
| MDR Report Key | 3653225 |
| Date Received | 2014-01-14 |
| Date of Report | 2014-01-13 |
| Date of Event | 2013-12-10 |
| Date Facility Aware | 2014-01-09 |
| Report Date | 2014-01-13 |
| Date Reported to FDA | 2014-01-13 |
| Date Reported to Mfgr | 2014-01-13 |
| Date Added to Maude | 2014-03-04 |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VENOUS WINDOW NEEDLE GUIDE (V-WING) |
| Generic Name | V-WING |
| Product Code | PFH |
| Date Received | 2014-01-14 |
| Returned To Mfg | 2014-01-13 |
| Model Number | 7 MM, DEPTH 8MM |
| Catalog Number | 0071 |
| Lot Number | 11-0093 |
| Device Expiration Date | 2013-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 15 MO |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VITAL ACCESS CORPORATION |
| Manufacturer Address | 2302 PRESIDENT DR. STU C WEST VALLEY CITY UT 84120 US 84120 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-01-14 |