FDA Adverse Event
Malfunction
Summary report: N
BIVONA CUSTOM TTS FLEXTEND TRACHEOSTOMY TUBE
MDR report key: 3172764
·
Received May 31, 2013
Report
- Report Number
- 2183502-2013-00278
- Event Type
- Malfunction
- Date Received
- May 31, 2013
- Date of Event
- May 3, 2013
- Report Date
- May 30, 2013
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- JOH
- PMA / PMN Number
- K944178
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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 WAS CAUSING THE PATIENT TO BECOME AGITATED, RESULTING IN INCREASED HEART AND RESPIRATORY RATES; THE PATIENT WAS UNABLE TO GET OXYGEN SATURATION ABOVE 90. REPLACEMENT WAS REQUIRED. NO PERMANENT ADVERSE EFFECTS TO PATIENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 241395 | BIVONA CUSTOM TTS FLEXTEND TRACHEOSTOMY TUBE | TRACHEOSTOMY TUBE | JOH | SMITHS MEDICAL ASD, INC. | NA | CL115503 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |