N
Patient 1
THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
MAUDE MDR 9899809
- MDR report key
- 9899809
- Report number
- 1416980-2020-01839
- Event key
- 0
- Event type
- 3
- Date received
- 2020-03-30
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- 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 | 3000 ML TPN BAG | SET, I.V. FLUID TRANSFER | BAXTER HEALTHCARE CORPORATION | LHI | NA | H938741 | ASKU | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-30 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT A 3000ML EVA (ETHYL VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAG WAS LEAKING FROM THE TOP SEAM. THE LEAK WAS DISCOVERED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.