MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-13 for BAXTER INTRAVIA EMPTY IV BAGS 500 ML manufactured by Baxter Healthcare Corp..
[183797570]
Baxter intravia containers were being used for compounding chemotherapy. Bag size 250 ml and 500 ml for two separate products. Plastic filaments were found floating in the bag. Pharmacy technician noted filament "fall" from the corner of the iv bag as one of the bags was being filled with saline.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093765 |
| MDR Report Key | 9834881 |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-03-06 |
| Date Added to Maude | 2020-03-16 |
| 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 | PHARMACIST |
| 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 | BAXTER INTRAVIA EMPTY IV BAGS 500 ML |
| Generic Name | CONTAINER, I.V, |
| Product Code | KPE |
| Date Received | 2020-03-13 |
| Lot Number | DR18813066 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE CORP. |
| Brand Name | BAXTER INTRAVIA 250 ML BAG |
| Generic Name | CONTAINER, I.V, |
| Product Code | KPE |
| Date Received | 2020-03-13 |
| Lot Number | DR17K23068 |
| Device Availability | * |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE CORP. |
| Product Code | --- |
| Date Received | 2020-03-13 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-13 |