3000 ML TPN BAG Adverse Event — Malfunction (MDR 1416980-2020-02430)
3000 ML TPN BAG Adverse Event — Malfunction (MDR 1416980-2020-02430) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: 3000 ML TPN BAG; Generic name: SET, I.V. FLUID TRANSFER; Manufacturer: BAXTER HEALTHCARE CORPORATION.
| Device | 3000 ML TPN BAG |
|---|---|
| Generic name | SET, I.V. FLUID TRANSFER |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Report number | 1416980-2020-02430 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, HEALTH |
| Narrative | THE LOT WAS MANUFACTURED BETWEEN SEPTEMBER 05, 2019 TO SEPTEMBER 07, 2019. THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. A FUNCTIONAL TESTING WAS PERFORMED WHICH REVEALED A LEAKAGE AT THE SPIKE PORT CAP FROM THE SPIKE PORT BASE. THE REPORTED CONDITION WAS VERIFIED. THE LIKELY CAUSE OF THE CONDITIO |
| Source | openFDA MAUDE (device adverse events) |
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