FDA Adverse Event
Injury
Summary report: N
BIVONA INNER CANNULA FOR BIVONA ADULT TRACHEOSTOMY TUBE
MDR report key: 3122522
·
Received May 16, 2013
Report
- Report Number
- 2183502-2013-00224
- Event Type
- Injury
- Date Received
- May 16, 2013
- Date of Event
- March 6, 2013
- Report Date
- May 15, 2013
- Manufacturer
- SMITHS MEDICAL ASD, INC
- Product Code
- JOH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVAL. 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 EVAL.
Description of Event or Problem · 1
USER FACILITY REPORTED THAT THE DEVICE WAS IN USE WITH PT. ACCORDING TO REPORTER THE ATTACHED VENTILATOR GAVE A "HIGH PRESSURE" ALARM DURING USE. ACCORDING TO THE REPORTER THE TREATING STAFF SUCTIONED THE TRACHEOSTOMY TUBE AND HAD SOME DIFFICULTY DURING THE PROCEDURE. THE TREATING STAFF REMOVED THE DEVICE FROM USE AND REPLACED WITH ANOTHER DEVICE. ACCORDING TO THE REPORTER, DEVICE HAD MUCUS PLUG AT ITS DISTAL END AND THE INNER CANNULA WAS NOT LONG ENOUGH FOR THE TRACHEOSTOMY TUBE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 217731 | BIVONA INNER CANNULA FOR BIVONA ADULT TRACHEOSTOMY TUBE | 38792 TUBE, TRACHEOSTOMY, REUSABLE | JOH | SMITHS MEDICAL ASD, INC | NA | 2263225 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |