SINGLE USE ASPIRATION NEEDLE Adverse Event — Malfunction (MDR 2951238-2020-00433)
SINGLE USE ASPIRATION NEEDLE Adverse Event — Malfunction (MDR 2951238-2020-00433) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: SINGLE USE ASPIRATION NEEDLE; Generic name: VIZISHOT 2 FLEX; Manufacturer: GYRUS ACMI, INC..
| Device | SINGLE USE ASPIRATION NEEDLE |
|---|---|
| Generic name | VIZISHOT 2 FLEX |
| Manufacturer | GYRUS ACMI, INC. |
| Report number | 2951238-2020-00433 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, USER F |
| Narrative | THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE DEVICE EVALUATION HISTORY RECORDS (DHR). PLEASE SEE UPDATED SECTIONS: G4, G7, H2, H3, H6 AND H10. THE DHR (NA-U403SX-4019 FR836420) FOR THIS PRODUCT HAVE BEEN REVIEWED. ALL RECORDS INDICATE THAT THE PRODUCT WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA. A TOTAL OF (B)(4) |
| Source | openFDA MAUDE (device adverse events) |
🔍 Search all device adverse events →
$1999/mo
Try DeviceEvents →