FDA Adverse Event
Malfunction
Summary report: N
BIVONA UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE
MDR report key: 3964001
·
Received May 22, 2014
Report
- Report Number
- 2183502-2014-00308
- Event Type
- Malfunction
- Date Received
- May 22, 2014
- Report Date
- May 15, 2014
- Manufacturer
- SMITHS MEDICAL INC.
- Product Code
- BTO
- PMA / PMN Number
- K912967
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
MANUFACTURER COMPLETED THE ENTIRE FORM. THE DEVICE IS CURRENTLY BEING EVALUATED; THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION ONCE IT IS COMPLETED. A SAMPLE DEVICE WAS RETURNED AND IS CURRENTLY UNDER INVESTIGATION.
Description of Event or Problem · 1
A REPORT WAS RECEIVED STATING THAT ONE OF THE EYELETS ON THE TRACHEOSTOMY TUBE FLANGE BROKE DURING USE. THE TUBE HAD BEEN IN SITUATION FOR AN UNKNOWN AMOUNT OF TIME PRIOR TO THE BREAKAGE. REPLACEMENT OF THE TUBE WAS REQUIRED. NO INCIDENT RELATED MEDICAL SEQUELA WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 306637 | BIVONA UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE | BTO - TRACHEOSTOMY TUBE AND TUBE CUFF | BTO | SMITHS MEDICAL INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |