FDA Adverse Event
Injury
Summary report: N
PORTEX BIVONA HYPERFLEX TTS¿ TRACHEOSTOMY TUBE
MDR report key: 8880975
·
Received August 9, 2019
Report
- Report Number
- 3012307300-2019-04094
- Event Type
- Injury
- Date Received
- August 9, 2019
- Report Date
- August 9, 2019
- Manufacturer
- SMITHS MEDICAL ASD; INC.
- Product Code
- JOH
- UDI-DI
- 10351688765727
- PMA / PMN Number
- K923878
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
INFORMATION WAS RECEIVED INDICATING THAT THE CUFF TO A SMITHS MEDICAL PORTEX BIVONA HYPERFLEX TTS TRACHEOSTOMY TUBE WAS REPORTED TO TAKE LONGER TO INFLATE. THE PATIENT'S MOTHER INDICATED THAT RESISTANCE WAS MET AND HAD TO PUSH HARDER TO INSERT THE WATER; CAUSING DISTRESS AND DISCOMFORT TO THE PATIENT. THE MOTHER REPORTED THAT INFLATION AND DEFLATION OF THE CUFF WAS PERFORMED PRIOR TO INSERTION AND HAD THE SAME DIFFICULTIES. A TRACH TUBE CHANGE OUT WAS NEEDED FOLLOWING PLACEMENT BUT THE CUFF WAS REPORTED TO TAKE LONGER TO DEFLATE. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 672744 | PORTEX BIVONA HYPERFLEX TTS¿ TRACHEOSTOMY TUBE | TUBE TRACHEOSTOMY AND TUBE CUFF | JOH | SMITHS MEDICAL ASD; INC. | 10351688765727 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Required Intervention |