FDA Adverse Event
Malfunction
Summary report: N
BIVONA TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE
MDR report key: 2881215
·
Received November 14, 2012
Report
- Report Number
- 2183502-2012-00541
- Event Type
- Malfunction
- Date Received
- November 14, 2012
- Date of Event
- October 11, 2012
- Report Date
- November 9, 2012
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- JOH
- PMA / PMN Number
- K914088
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
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 F/U REPORT DETAILING THE RESULTS OF THE EVAL.
Description of Event or Problem · 1
A REPORT WAS REC'D THAT ALLEGES THAT THE TRACHEOSTOMY TUBE BROKE AT THE CONNECTOR DURING REPLACEMENT OF THE TRACHEOSTOMY TUBE NECKSTRAP. 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 - TRACHEOSTOMY TUBE | JOH | SMITHS MEDICAL ASD, INC. | NA | 2296651 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |