MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-10-10 for B/BRAUN 3-IN-1 MIXING CONT * 59980-10 manufactured by B.braun Medical, Inc..
[293185]
While filling 1000 ml 3:1 mixing container with tpn solution the tech noticed material imbedded in the plastic of the hyper former filling port. When filled with lipid tpn the foreign material was made more visible.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1029876 |
| MDR Report Key | 492319 |
| Date Received | 2003-10-14 |
| Date of Report | 2003-10-08 |
| Date of Event | 2003-10-08 |
| Date Added to Maude | 2003-10-31 |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | B/BRAUN 3-IN-1 MIXING CONT |
| Generic Name | 3:1 MIXING CONTAINER 1000 ML |
| Product Code | MYJ |
| Date Received | 2003-10-10 |
| Model Number | * |
| Catalog Number | 59980-10 |
| Lot Number | 060461837 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 481020 |
| Manufacturer | B.BRAUN MEDICAL, INC. |
| Manufacturer Address | * BETHLEHEM PA 18018 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-10-14 |