FDA Adverse Event
Malfunction
Summary report: N
BLUE LINE PEDIATRIC TRACHEOSTOMY TUBE
MDR report key: 81397
·
Received April 3, 1997
Report
- Report Number
- 1217052-1997-00017
- Event Type
- Malfunction
- Date Received
- April 3, 1997
- Date of Event
- February 1, 1997
- Manufacturer
- SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.
- Product Code
- BTO
- Report Source
- Manufacturer report
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BLUE LINE PEDIATRIC TRACHEOSTOMY TUBE | TRACHEOSTOMY TUBE AND TUBE CUFF | BTO | SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | VENTILATOR AND VENTILATOR CIRCUIT |