FDA Adverse Event
Malfunction
Summary report: N
BIVONA TTS TRACHEOSTOMY TUBE
MDR report key: 3220619
·
Received June 25, 2013
Report
- Report Number
- 2183502-2013-00342
- Event Type
- Malfunction
- Date Received
- June 25, 2013
- Date of Event
- May 27, 2013
- Report Date
- June 24, 2013
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- JOH
- PMA / PMN Number
- K913859
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- 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 WAS LEAKING AT THE CUFF AFTER AN UNKNOWN AMOUNT OF TIME IN USE. REPLACEMENT WAS REQUIRED. NO INCIDENT RELATED MEDICAL SEQUELA WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 286809 | BIVONA TTS TRACHEOSTOMY TUBE | JOH - TRACHEOSTOMY TUBE | JOH | SMITHS MEDICAL ASD, INC. | NA | 2380139 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |