FDA Adverse Event
Injury
Summary report: N
BIVONA UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE
MDR report key: 3955168
·
Received July 17, 2014
Report
- Report Number
- 2183502-2014-00498
- Event Type
- Injury
- Date Received
- July 17, 2014
- Report Date
- July 15, 2014
- Manufacturer
- SMITHS MEDICAL MD, INC.
- Product Code
- JOH
- PMA / PMN Number
- K083641
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- LAY USER/PATIENT
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MFR WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.
Description of Event or Problem · 1
A REPORT WAS RECEIVED STATING THAT THE DEVICE WAS IN USE WITH A PT WHEN IT WAS OBSERVED THAT THE TRACHEOSTOMY TUBE WAS NOT SITTING PROPERLY IN THE PT'S TRACHEA. AN EXCHANGE OF THE TRACHEOSTOMY TUBE WAS PERFORMED. NO PERMANENT ADVERSE EFFECTS TO PT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 420061 | BIVONA UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE | JOH - TRACHEOSTOMY TUBE | JOH | SMITHS MEDICAL MD, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 6 YR | Required Intervention |