MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-18 for MINI-BAG PLUS CONTAINER manufactured by Baxter Healthcare Corporation.
[134019010]
A baxter mini bag plus 100ml container was found to have significantly less fluid than 100ml, approx half the volume. The bag appeared completely dry, and there did not seem to be any leaks or breaks in the bag. However, upon closer inspection, when the bag was squeezed, drops of fluid leaked from the junction between the bag and the blue vial adapter piece. Strength: 100 ml millilitre(s). Therapy start date: (b)(6) 2019.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5083257 |
| MDR Report Key | 8266913 |
| Date Received | 2019-01-18 |
| Date of Report | 2019-01-17 |
| Date of Event | 2019-01-16 |
| Date Added to Maude | 2019-01-22 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MINI-BAG PLUS CONTAINER |
| Generic Name | EQUIPMENT, LABORATORY, GENERAL PURPOSE |
| Product Code | LXG |
| Date Received | 2019-01-18 |
| Lot Number | P385831 |
| Device Expiration Date | 2019-10-31 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-18 |