FDA Adverse Event
Injury
Summary report: N
SMITHS MEDICAL BLUE LINE ULTRA TRACHEOSTOMY KIT
MDR report key: 8545274
·
Received April 24, 2019
Report
- Report Number
- 3012307300-2019-02251
- Event Type
- Injury
- Date Received
- April 24, 2019
- Date of Event
- December 4, 2018
- Report Date
- April 24, 2019
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- OGW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
INFORMATION WAS RECEIVED THAT WHILE A PATIENT UNDER LOCAL ANESTHESIA FOR CEREBRAL INFARCTION, WAS USING A SMITHS MEDICAL TRACHEAL TUBE KIT. IT WAS REPORTED THAT PATIENT'S WOUND WAS OOZING AND AIR LEAKS WERE NOTED IN THE BALLOON. THE TUBE WAS REPLACED IMMEDIATELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 336959 | SMITHS MEDICAL BLUE LINE ULTRA TRACHEOSTOMY KIT | TRACHEOSTOMY | OGW | SMITHS MEDICAL ASD, INC. | 3484641 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |