CLEARLINK SOLUTION SET Adverse Event — Malfunction (MDR 1416980-2020-02394)
CLEARLINK SOLUTION SET Adverse Event — Malfunction (MDR 1416980-2020-02394) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: CLEARLINK SOLUTION SET; Generic name: SET, ADMINISTRATION, INTRAVASCULAR; Manufacturer: BAXTER HEALTHCARE CORPORATION.
| Device | CLEARLINK SOLUTION SET |
|---|---|
| Generic name | SET, ADMINISTRATION, INTRAVASCULAR |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Report number | 1416980-2020-02394 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | THE DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED, AND IT WAS NOTED THAT THE POST OF THE Y-SITE CLEARLINK WAS NOT ASSEMBLED CORRECTLY. THE OTHER COMPONENTS WERE CORRECTLY PLACED AND ACCORDING TO SPECIFICATIONS. PRESSURE TESTING AND CLEAR PASSAGE UNDER WATER TESTING WAS PERFORMED, AND IT WAS NOTED THAT THERE WAS LEAK IN THE GLAND OF THE Y-SITE CLEARLINK. THE REPORTED CONDITI |
| Source | openFDA MAUDE (device adverse events) |
🔍 Search all device adverse events →
$1999/mo
Try DeviceEvents →