D
Patient 1
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.
MAUDE MDR 492319
- MDR report key
- 492319
- Report number
- MW1029876
- Event key
- 0
- Event type
- 3
- Date of event
- 2003-10-08
- Date received
- 2003-10-14
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 109
- Health professional
- 3
- Initial report to FDA
- 0
- Event location
- 3
Manufacturer Contact#
- Report source
- P
- Manufacturer link flag
- N
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | B/BRAUN 3-IN-1 MIXING CONT | 3:1 MIXING CONTAINER 1000 ML | B.BRAUN MEDICAL, INC. | MYJ | * | 59980-10 | 060461837 | N | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2003-10-14 | 0 | 1. O |