N
Patient 1
THE DEVICE WAS RECEIVED AND IS CURRENTLY AWAITING EVALUATION COMPLETION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
MAUDE MDR 9885116
- MDR report key
- 9885116
- Report number
- 1416980-2020-01732
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-02-06
- Date received
- 2020-03-26
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 109
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Address
- 25212 W. ILLINOIS ROUTE 120 ROUND LAKE IL 60073 US
- Phone
- 224-224-2242
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EVA TPN 3000 ML TPN BAG | SET, I.V. FLUID TRANSFER | BAXTER HEALTHCARE CORPORATION | LHI | NA | H938741 | 60205999 | N | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-26 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED A 3000ML EVA (ETHYL VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAG LEAKED FROM UNSPECIFIED LOCATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.