FDA Adverse Event
Malfunction
Summary report: N
BIVONA UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE
MDR report key: 3003454
·
Received February 11, 2013
Report
- Report Number
- 2183502-2013-00020
- Event Type
- Malfunction
- Date Received
- February 11, 2013
- Date of Event
- January 2, 2013
- Report Date
- February 8, 2013
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- JOH
- PMA / PMN Number
- K912469
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT ALLEGES THAT THE TRACHEOSTOMY TUBE REQUIRED REMOVAL AND REPLACEMENT. IT IS ALLEGED THAT AFTER AN UNK AMOUNT TIME IN SITU THE TRACHEOSTOMY TUBE TORE NEAR THE FLANGE. NO INCIDENT RELATED MEDICAL SEQUELA WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 60391 | BIVONA UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE | JOH - TUBE TRACHEOSTOMY AND TUBE CUFF | JOH | SMITHS MEDICAL ASD, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |