CLEARLINK SOLUTION SET Adverse Event — Malfunction (MDR 1416980-2020-02416)
CLEARLINK SOLUTION SET Adverse Event — Malfunction (MDR 1416980-2020-02416) 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 | 1416980-2020-02416 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | ADDITIONAL INFORMATION WAS ADDED TO D10, H3 AND H6. H10: THE DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED WHICH OBSERVED THAT THE FILTER AND MEMBRANE ARE DAMAGED. A FUNCTIONAL TEST INCLUDING PRESSURE TEST AND CLEAR PASSAGE TEST WAS PERFORMED AND A LEAK WAS IDENTIFIED. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION IS RELATED TO A SUPPLIER MANUFACTURING ISS |
| Source | openFDA MAUDE (device adverse events) |
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