MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-01 for I.V. BAG manufactured by Baxter Healthcare (gambro).
[84740798]
Prismasol (baxter) a product for renal crrt, previously was labeled with a sticker that contained lot and expiration dating. This information is now printed directly onto the plastic of the prismasol bag inside of the overwrap. The moisture between the bag and the overwrap causes the lot and expiration to be obscured or removed. It is difficult or impossible to find lot and expiration dating on this product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5071908 |
| MDR Report Key | 6839049 |
| Date Received | 2017-09-01 |
| Date of Report | 2017-08-30 |
| Date of Event | 2017-08-30 |
| Date Added to Maude | 2017-09-01 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | I.V. BAG |
| Generic Name | CONTAINER I.V. |
| Product Code | KPI |
| Date Received | 2017-09-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE (GAMBRO) |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-01 |