N
Patient 1
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.
MAUDE MDR 6096892
- MDR report key
- 6096892
- Report number
- 1820334-2016-01294
- Event key
- 0
- Event type
- 3
- Date received
- 2016-11-11
- 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
- MRS. RITA HARDEN
- Address
- 750 DANIELS WAY BLOOMINGTON IN 47404 US
- Phone
- 812-812-8128
- Report source
- M
- Manufacturer link flag
- Y
Devices#
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-11-11 | 0 | 1. R |
Event Narratives#
D
Patient 1
THE AIC WAS LOADED OVER THE FIBEROPTIC BRONCHOSCOPE AND THEN PASSED THROUGH THE CLMA INTO THE TRACHEA. AFTER CONFIRMATION OF TRACHEAL PLACEMENT WITH THE FIBERSCOPE, THE FIBERSCOPE AND LMA WERE REMOVED, LEAVING THE AIC AT THE 34 CM MARK AT THE MOUTH ANGLE. ANOTHER MANUFACTURER'S ENDOTRACHEAL TUBE WAS THEN INTRODUCED OVER THE AIC. UNFORTUNATELY, THE AIC BROKE AT THE LEVEL OF THE MOUTH ANGLE AND WAS LEFT IN THE TRACHEA. THE PATIENT REGAINED SPONTANEOUS BREATHING AT THIS TIME AND 3.0 L/MIN OF OXYGEN WAS ADMINISTERED BY NASAL CANNULA. THE FACILITY TRIED TO EXTRACT THE AIC BY ENDOSCOPE, BUT FAILED DUE TO THE SLIPPERY SURFACE OF THE SHEARED AIC. VENTILATION WAS MAINTAINED AGAIN BY CLMA. A SURGICAL AIRWAY (TRACHEOSTOMY) WAS ESTABLISHED TO REMOVE THE AIC. FOLLOWING REMOVAL, RETROGRADE INSERTION OF A 16-FRENCH NASOGASTRIC TUBE WAS PERFORMED THROUGH THE ORIFICE OF THE TRACHEOSTOMY TO THE ORAL CAVITY. THE NASOGASTRIC TUBE SERVED AS AN INTRODUCER AND GUIDED THE ETT INTO THE TRACHEA. THE OPERATION PROGRESSED SMOOTHLY AND THE PATIENT WAS DISCHARGED UNEVENTFULLY.