FDA Adverse Event
Injury
Summary report: N
BIVONA AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE
MDR report key: 2072647
·
Received April 21, 2011
Report
- Report Number
- 2183502-2011-00184
- Event Type
- Injury
- Date Received
- April 21, 2011
- Date of Event
- March 24, 2011
- Report Date
- April 21, 2011
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- JOH
- PMA / PMN Number
- K914088
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, 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
DURING A SCHEDULED TRACH CHANGE THE CUFF OF THE TRACH TUBE WAS UNABLE TO BE FULLY DEFLATED. THE TRACH TUBE WAS FORCEFULLY REMOVED IN THE OPERATING ROOM. THE TRACH TUBE WAS REPLACED AND NO LONG TERM MEDICAL SEQUELA WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIVONA AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE | JOH-TRACHEOSTOMY TUBE | JOH | SMITHS MEDICAL ASD, INC. | NA | 1864908 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |