FDA Adverse Event
Malfunction
Summary report: N
BIVONA FLEXTRND TS TRACHEOSTOMY TUBE
MDR report key: 3963862
·
Received May 21, 2014
Report
- Report Number
- 2183502-2014-00323
- Event Type
- Malfunction
- Date Received
- May 21, 2014
- Report Date
- May 20, 2014
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- JOH
- PMA / PMN Number
- K923878
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE IS CURRENTLY BEING EVALUATED; THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION ONCE IT IS COMPLETED.
Description of Event or Problem · 1
USER FACILITY REPORTED THAT DURING INSPECTION OF TH LISTED IN SITU TRACHEOSTOMY TUBE, LACERATIONS WERE FOUND ON THE TUBE'S SILICONE MATERIAL. FOLLOWING DISCOVERY OF THE DAMAGE, AN EMERGENT EXCHANGE OF THE TRACHEOSTOMY TUBE WAS PERFORMED. THE REPORT STATES THAT THE LACERATIONS IN THE SILICONE APPEAR TO CORRESPOND WITH THE TUBE'S INNER METAL COIL. THERE WERE NO PERMANENT ADVERSE EFFECTS TO PATIENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 301190 | BIVONA FLEXTRND TS TRACHEOSTOMY TUBE | TUBE TRACHEOSTOY AND TUBE CUFF | JOH | SMITHS MEDICAL ASD, INC. | NA | CS10692 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |