FDA Adverse Event
Summary report: N
FLEXIBAND CUFFED ORAL RAE TRACHEAL TUBE WITH CUFF, 8.0
MDR report key: 20494
·
Received February 23, 1995
Report
- Report Number
- MW4000673
- Date Received
- February 23, 1995
- Report Date
- February 23, 1995
- Manufacturer
- SHERIDAN CATHETER CORP.
- Product Code
- BTR
- Report Source
- Voluntary report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A 20-YEAR-OLD MALE PT WAS SCHEDULED FOR A SEPTOPLASTY/FESS UNDER GENERAL ANESTHESIA AND WAS INTUBATED. THE CASE PROCEEDED UNEVENTFUL UNTIL THE EMERGENCE FROM ANESTHESIA FOLLOWING THE CONCLUSION OF THE SURGERY. THE PT WAS EXTUBATED FULLY REFLEXIC, BUT THE DISTAL PORTION OF THE TUBE DISCONNECTED AND WAS RETAINED IN THE PT'S TRACHEA, AND WAS REMOVED BY GRASPING WITH HEMOSTATS TO PREVENT FURTHER MIGRATION INTO THE PT'S LUNGS. THIS PARTICULAR TYPE PRESENTS POTENTIAL LOSS OF PT'S AIRWAY, POSSIBLY DEATH AND SHOULD NOT BE USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLEXIBAND CUFFED ORAL RAE TRACHEAL TUBE WITH CUFF, 8.0 | BTR | SHERIDAN CATHETER CORP. | 016363 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 YR |