FDA Adverse Event
Injury
Summary report: N
BIVONA UNCUFFED PEDIATRIC FLEX TEND PLUS TRACHEOSTOMY TUBE
MDR report key: 2122936
·
Received June 9, 2011
Report
- Report Number
- 2183502-2011-00464
- Event Type
- Injury
- Date Received
- June 9, 2011
- Date of Event
- April 21, 2011
- Report Date
- June 7, 2011
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- JOH
- PMA / PMN Number
- K944178
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVAL. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MFR WILL FILE A F/U REPORT DETAILING THE RESULTS OF THE EVAL.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT STATES THAT A VENTILATOR HOSE COULD NOT BE REMOVED FROM THE 15MM CONNECTOR OF THE IN SITU TRACHEOSTOMY TUBE. AN EMERGENT REPLACEMENT WAS REQUIRED. NO FURTHER INCIDENT RELATED MEDICAL SEQUELA WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIVONA UNCUFFED PEDIATRIC FLEX TEND PLUS TRACHEOSTOMY TUBE | JOH - TRACHEOSTOMY TUBE | JOH | SMITHS MEDICAL ASD, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |