FDA Adverse Event
Malfunction
Summary report: N
BIVONA TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE
MDR report key: 2843795
·
Received October 25, 2012
Report
- Report Number
- 2183502-2012-00498
- Event Type
- Malfunction
- Date Received
- October 25, 2012
- Report Date
- October 24, 2012
- Manufacturer
- SMITHS MEDICAL MD, INC.
- Product Code
- JOH
- PMA / PMN Number
- K914088
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- UNKNOWN
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 FOLLOW UP REPORT DETAILING THE RESULTS OF THE EVAL.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT ALLEGES THAT THE PILOT BALLOON BECAME DETACHED FROM THE INFLATION LINE OF THE IN SITU TRACHEOSTOMY TUBE. REPLACEMENT WAS REQUIRED. NO INCIDENT RELATED MEDICAL SEQUELA WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIVONA TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE | JOH | SMITHS MEDICAL MD, INC. | NA | 2188226 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |