FDA Adverse Event
Injury
Summary report: N
BIVONA
MDR report key: 11098796
·
Received December 30, 2020
Report
- Report Number
- 3012307300-2020-12876
- Event Type
- Injury
- Date Received
- December 30, 2020
- Date of Event
- November 23, 2020
- Report Date
- December 31, 2020
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- JOH
- UDI-DI
- 15021312013856
- PMA / PMN Number
- K081440
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
INFORMATION RECEIVED A SMITHS MEDICAL TRACHEOSTOMY/SILICONE - BIVONA TUBES ADULT HYPERFLEX MALFUNCTIONED. WHEN THE TRACH TUBE WAS USED, IT WAS FOUND THAT THE CUFF WAS LEAKING. CUSTOMER RESPONSE REVEALED AN TRACHEOSTOMY TUBE CHANGE OUT WAS REQUIRED. FILE NOW SEROUS INJURY REPORTABLE. AS UNKNOWN IF NEW TRACHEOSTOMY VERSES LONG TERM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1558817 | BIVONA | TRACHEOSTOMY | JOH | SMITHS MEDICAL ASD, INC. | 8.00MM | 3730900 | 15021312013856 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |