FDA Adverse Event
Injury
Summary report: N
PORTEX® BIVONA® ADULT TTS¿ HYPERFLEX¿ TRACHEOSTOMY TUBES
MDR report key: 7806001
·
Received August 22, 2018
Report
- Report Number
- 3012307300-2018-03321
- Event Type
- Injury
- Date Received
- August 22, 2018
- Date of Event
- July 25, 2018
- Report Date
- August 22, 2018
- Manufacturer
- SMITHS MEDICAL ASD; INC.
- Product Code
- JOH
- UDI-DI
- 15021312013818
- PMA / PMN Number
- K081440
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(6).
Description of Event or Problem · 1
INFORMATION WAS RECEIVED INDICATING THAT THREE DAYS FOLLOWING INSERTION OF A SMITHS MEDICAL PORTEX® BIVONA® ADULT TTS¿ HYPERFLEX¿ TRACHEOSTOMY TUBE A CUFF LEAK WAS NOTED. THE PATIENT'S FAMILY NOTED THAT THERE WAS NO AIR LEAK PRESENT UPON TRACHEOSTOMY (TRACH) TUBE CHANGE OUT. THE FAMILY ALSO SPECULATED THAT THE CUFF MEMBRANE MAY HAVE BECOME THINNER OR THAT THE MATERIAL HAS CHANGED. THE TUBE WAS REQUIRED TO BE CHANGED OUT WITH NO REPORTED ADVERSE EFFECTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 648670 | PORTEX® BIVONA® ADULT TTS¿ HYPERFLEX¿ TRACHEOSTOMY TUBES | TUBE TRACHEOSTOMY AND TUBE CUFF | JOH | SMITHS MEDICAL ASD; INC. | 3418061 | 15021312013818 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |