N
Patient 1
INITIAL SUBMISSION. THE SAMPLE HAS BEEN RECEIVED. THE SAMPLE IS BEING SENT TO THE MANUFACTURER TO EVALUATE THE REPORTED ISSUE. ONCE THE EVALUATION IS COMPLETED A FOLLOW UP SUBMISSION WILL BE FILED.
MAUDE MDR 6826657
- MDR report key
- 6826657
- Report number
- 3010838917-2017-00034
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-07-23
- Date received
- 2017-08-29
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MINDY FABER
- Address
- 26125 NORTH RIVERWOODS BLVD. METTAWA IL 60045 US
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | INFUSOR, PRESSURE, FOR I.V. BAGS | INFUSOR, PRESSURE, 1000 ML, CLEAR, 20/CS | VYAIRE MEDICAL, INC | KZD | IN900020 | 164592 | R | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-08-29 | 0 | 1. R |
Event Narratives#
D
Patient 1
CUSTOMER REPORTED VIA EMAIL: ?BECAUSE OF THE STICKINESS OF THE PLASTIC ? IT?S REALLY DIFFICULT TO SLIDE IT INTO THE PRESSURE BAG ? ALMOST A 5? PROCEDURE TO GET INTO THE BAG, AFTER THEIR ROUTINE WORK AROUND OF FLUSHING SOME OF THE FLUID OUT OF THE BAG TO MAKE IT EASIER TO SLIDE IN. 5? WE ARE HAVING RUN OUT AS MUCH AS 100 ML OUT OF THE IV BAG TO GET IT INTO THE PRESSURE BAG. ONE OF THE MORE SURPRISING WORK AROUND WAS PUTTING LUBRICANT ON THE OUTSIDE OF THE BAG TO SLIDE IT IN. THE PATIENT'S BP WAS IN THE 50'S OR 70'S.?