FDA Adverse Event
Injury
Summary report: N
BIVONA TTS TRACHEOSTOMY TUBE
MDR report key: 3203717
·
Received June 25, 2013
Report
- Report Number
- 2183502-2013-00346
- Event Type
- Injury
- Date Received
- June 25, 2013
- Date of Event
- May 6, 2013
- Report Date
- June 24, 2013
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- JOH
- PMA / PMN Number
- K913859
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, 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 DEFLATING AT THE CUFF AFTER SEVERAL DAYS IN SITU. REPLACEMENT WAS REQUIRED. NO INCIDENT RELATED MEDICAL SEQUELA WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 287751 | BIVONA TTS TRACHEOSTOMY TUBE | JOH-TRACHEOSTOMY TUBE | JOH | SMITHS MEDICAL ASD, INC. | NA | 2199728 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |