FDA Adverse Event
Injury
Summary report: N
PORTEX BIVONA HYPERFLEX TRACHEOSTOMY TUBE
MDR report key: 9788657
·
Received March 4, 2020
Report
- Report Number
- 3012307300-2020-01764
- Event Type
- Injury
- Date Received
- March 4, 2020
- Date of Event
- January 24, 2020
- Report Date
- March 4, 2020
- Manufacturer
- SMITHS MEDICAL ASD; INC.
- Product Code
- JOH
- UDI-DI
- 15021312015690
- PMA / PMN Number
- K081440
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL PORTEX® BIVONA® HYPERFLEX¿ TRACHEOSTOMY TUBE WAS REPORTED TO NOT BE HOLDING VOLUME. AIR WAS ADDED AND YET AGAIN WAS NOT HOLDING WATER. AFTER 10 MINUTES OF BEING IN USE, A TRACH TUBE CHANGE OUT WAS PERFORMED. THERE WERE NO REPORTED ADVERSE EFFECTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 249791 | PORTEX BIVONA HYPERFLEX TRACHEOSTOMY TUBE | TUBE TRACHEOSTOMY AND TUBE CUFF | JOH | SMITHS MEDICAL ASD; INC. | 75FHXL80 | 3861046 | 15021312015690 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |