FDA Adverse Event
Injury
Summary report: N
BIVONA CUSTOM TTS FLEXTEND TRACHEOSTOMY TUBE
MDR report key: 3131032
·
Received May 20, 2013
Report
- Report Number
- 2183502-2013-00235
- Event Type
- Injury
- Date Received
- May 20, 2013
- Date of Event
- April 17, 2013
- Report Date
- May 17, 2013
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- JOH
- PMA / PMN Number
- K944178
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- UNKNOWN
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
A REPORT WAS REC'D THAT ALLEGES THE TRACHEOSTOMY TUBE SPLIT NEAR THE CONNECTION OF THE TRACHEOSTOMY TUBE AND FLANGE AFTER AN UNK AMOUNT OF TIME IN USE. THE PT REQUIRED EMERGENCY TRACHEOSTOMY TUBE CHANGE. NO INCIDENT RELATED MEDICAL SEQUELA WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 223507 | BIVONA CUSTOM TTS FLEXTEND TRACHEOSTOMY TUBE | TRACHEOSTOMY TUBE | JOH | SMITHS MEDICAL ASD, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |