2000 ML TPN BAG Adverse Event — Malfunction (MDR 1416980-2020-02431)
2000 ML TPN BAG Adverse Event — Malfunction (MDR 1416980-2020-02431) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: 2000 ML TPN BAG; Generic name: SET, I.V. FLUID TRANSFER; Manufacturer: BAXTER HEALTHCARE CORPORATION.
| Device | 2000 ML TPN BAG |
|---|---|
| Generic name | SET, I.V. FLUID TRANSFER |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Report number | 1416980-2020-02431 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, HEALTH |
| Narrative | ADDITIONAL INFORMATION WAS ADDED TO H4 AND H6. H4: THE LOT WAS MANUFACTURED BETWEEN NOVEMBER 25, 2019 TO NOVEMBER 26, 2019. H10: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION |
| Source | openFDA MAUDE (device adverse events) |
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