FDA Adverse Event
Death
Summary report: N
SHERIDAN CR ENDOTRACHEAL TUBE, 8.0
MDR report key: 627093
·
Received August 15, 2005
Report
- Report Number
- 2014730-2005-00014
- Event Type
- Death
- Date Received
- August 15, 2005
- Date of Event
- July 11, 2005
- Report Date
- August 15, 2005
- Manufacturer
- TELEFLEX MEDICAL/HUDSON RCI LEX MEDICAL
- Product Code
- BTR
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
IT WAS ALLEGED THAT A PATIENT POST-OP IN THE ICU ARRESTED REQUIRING INTUBATION. DURING INTUBATION THE CUFF WAS REPORTED TO LEAK . THIS ALLEGEDLY OCCURRED WITH THREE DIFFERENT SIZE TUBES ON THE SAME PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SHERIDAN CR ENDOTRACHEAL TUBE, 8.0 | ENDOTRACHEAL TUBE | BTR | TELEFLEX MEDICAL/HUDSON RCI LEX MEDICAL | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Death| O| R |