FDA Adverse Event
Malfunction
Summary report: N
PHYCON
MDR report key: 1787780
·
Received July 29, 2010
Report
- Report Number
- 1787780
- Event Type
- Malfunction
- Date Received
- July 29, 2010
- Date of Event
- July 22, 2010
- Report Date
- July 29, 2010
- Manufacturer
- FUJI SYSTEMS CORPORATION-VITAID LTD.
- Product Code
- BTR
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA, US
Narratives
Description of Event or Problem · 1
BALLOON WAS BLOWN UP AND DID NOT HOLD PRESSURE. MD CAME TO OPERATING ROOM SUPERVISOR WITH A CONCERN ABOUT THE PRODUCT MADE BY PHYCON, AN 8.5 UNIVENT TUBE THAT HE USED IN A LUNG OPERATION. THE TUBE HAS A SMALL BALLOON THAT IS POSITIONED VIA BRONCHOSCOPE TO OCCLUDE A LOBE OF THE LUNG SO IT IS NOT INFLATING AND DEFLATING WHILE THE SURGEON WORKS ON IT. THE CAPACITY OF THIS SMALL BALLOON IS 6CC, AND IT POPPED AT 3CC, AND THE TUBE HAD TO BE REPLACED WHILE THE PATIENT WAS POSITIONED ON HIS SIDE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PHYCON | TUBE, TRACHEAL (W/WO CONNECTOR) | BTR | FUJI SYSTEMS CORPORATION-VITAID LTD. | TCB UNIVENT | 2702415 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR | NONE KNOWN| NO OTHER THERAPIES |