D
Patient 1
THE EVENT IS REPORTED AS: THE CUFF OF THE ENDOTRACHEAL TUBE LEAKED DURING INTUBATION. THE TUBE WAS REMOVED AND THE PT RE-INTUBATED. THE CUFF OF THE ENDOTRACHEAL TUBE WAS NOT PRE-INFLATED. NO REPORT OF PT INJURY.
MAUDE MDR 3000134
- MDR report key
- 3000134
- Report number
- 8040412-2013-00049
- Event key
- 0
- Event type
- 3
- Date of event
- 2013-02-26
- Date received
- 2013-03-08
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 2
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- MARGIE BURTON, RN
- Address
- P.O. BOX 12600 DURHAM NC 27709 US
- Phone
- 919-919-9194
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | RUSCH AGT NASAL PERFORMED ET TUBE, 7.0MM | CUFFED ENDOTRACHEAL TUBE | TELEFLEX MEDICAL | BSK | 111781070 | 12GG44 | R | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2013-03-08 | 0 |
Event Narratives#
N
Patient 1
THE DEVICE SAMPLE WAS NOT RETURNED FOR EVAL AT THE TIME OF THIS REPORT.