FDA Adverse Event
Malfunction
Summary report: N
PORTEX® BIVONA® ADULT TTS TRACHEOSTOMY TUBES ADD TO INQUIRY ADD TO BROCHURE
MDR report key: 5144832
·
Received October 13, 2015
Report
- Report Number
- 2183502-2015-00750
- Event Type
- Malfunction
- Date Received
- October 13, 2015
- Date of Event
- September 21, 2015
- Report Date
- October 12, 2015
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- JOH
- PMA / PMN Number
- K083641
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
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 STATING THAT THE LISTED TRACHEOSTOMY TUBE WAS FOUND LEAKING AT THE CUFF AFTER A FEW DAYS OF USE. THE PATIENT'S IN-HOME CARE TAKER DISCOVERED THE DEVICE LEAK. AFTER DISCOVERY, THE CARE TAKER MONITORED THE CUFF PRESSURE EVERY 20-40 MINS AND REFLATED THE CUFF TO 4CC OF AIR WHEN NECESSARY. THE TRACHEOSTOMY TUBE WAS NOT NEW; IT HAD BEEN REPROCESSED TWO TIMES PRIOR THE REPORTED EVENT. NO INCIDENT RELATED MEDICAL SEQUELA REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 675864 | PORTEX® BIVONA® ADULT TTS TRACHEOSTOMY TUBES ADD TO INQUIRY ADD TO BROCHURE | TRACHEOSTOMY TUBE | JOH | SMITHS MEDICAL ASD, INC. | NA | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |