MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-11 for EXACTAMIX 500 ML EVA CONTAINER manufactured by Baxter Healthcare Corporation.
[179312699]
There is a leak in the port with the green clip of the exactamix 500 ml eva container. This occurred during med production and did not reach pt interaction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092949 |
| MDR Report Key | 9699775 |
| Date Received | 2020-02-11 |
| Date of Report | 2020-02-07 |
| Date of Event | 2020-02-06 |
| Date Added to Maude | 2020-02-12 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXACTAMIX 500 ML EVA CONTAINER |
| Generic Name | SYSTEM / DEVICE, PHARMACY COMPOUNDING |
| Product Code | NEP |
| Date Received | 2020-02-11 |
| Lot Number | 60187198 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Product Code | --- |
| Date Received | 2020-02-11 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-11 |