FDA Adverse Event
Injury
Summary report: N
NIM EMG ENDOTRACHEAL TUBE
MDR report key: 1812201
·
Received August 18, 2010
Report
- Report Number
- MW5017151
- Event Type
- Injury
- Date Received
- August 18, 2010
- Date of Event
- August 9, 2010
- Report Date
- August 11, 2010
- Manufacturer
- MEDTRONIC XOMED INC.
- Product Code
- BTR
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- HI, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
PT WAS INTUBATED BY ANESTHESIA MD. AN AIR LEAK WAS HEARD AND THE DOCTOR REMOVED THE TUBE. HE NOTICED THE ET TUBE HAD A WIRE STICKING THROUGH THE CUFF APPROX 1/4 INCH. A NEW ET TUBE WAS OPENED, BALLOON CHECKED AND PT WAS REINTUBATED. THERE WAS NO HARM TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NIM EMG ENDOTRACHEAL TUBE | ET TUBE | BTR | MEDTRONIC XOMED INC. | REF. 8229307 | 65667300 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Hospitalization |