MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-19 for PAB MIXING CONTAINER manufactured by B Braun Medical Inc..
[180632656]
While making an iv solution within an empty pab bag, a floater was noticed in the solution. This floater appeared to be a part of the bag that had somehow gotten dislodged or broken off during manipulation. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093135 |
| MDR Report Key | 9733654 |
| Date Received | 2020-02-19 |
| Date of Report | 2020-02-17 |
| Date of Event | 2020-02-13 |
| Date Added to Maude | 2020-02-20 |
| 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 | PAB MIXING CONTAINER |
| Generic Name | CONTAINER, I.V. |
| Product Code | KPE |
| Date Received | 2020-02-19 |
| Lot Number | J8J710 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B BRAUN MEDICAL INC. |
| Product Code | --- |
| Date Received | 2020-02-19 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-19 |