FDA Adverse Event
Malfunction
Summary report: N
500 ML TPN BAG
MDR report key: 8000216
·
Received October 24, 2018
Report
- Report Number
- 1416980-2018-06741
- Event Type
- Malfunction
- Date Received
- October 24, 2018
- Report Date
- November 28, 2018
- Manufacturer
- SET, I.V. FLUID TRANSFER
- Product Code
- LHI
- UDI-DI
- 00085412477220
- PMA / PMN Number
- K900585
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative · 1
A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT TEN (10) 500ML EVA (ETHYL VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAGS WERE LEAKING. THE LEAKS WERE DISCOVERED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 840478 | 500 ML TPN BAG | SET, I.V. FLUID TRANSFER | LHI | SET, I.V. FLUID TRANSFER | NA | 60108274 | 00085412477220 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |