FDA Adverse Event
Malfunction
Summary report: N
BIVONA REDIATRIC FLEXTEND TRACHEOSTOMY TUBE
MDR report key: 295334
·
Received August 30, 2000
Report
- Report Number
- 1824231-2000-00002
- Event Type
- Malfunction
- Date Received
- August 30, 2000
- Date of Event
- July 2, 2000
- Report Date
- August 29, 2000
- Manufacturer
- BIVONA MEDICAL TECHNOLOGIES
- Product Code
- BTO
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
VENTILATOR ALARMED DURING THE NIGHT. PT DISCOVERED IN RESPIRATORY DISTRESS. TRACHEOSTOMY TUBE REPLACED. REMOVED TUBE FOUND TO BE BROKEN AT PROXIMAL END JUST BELOW SWIVEL AND EXTERNAL TO PT. PT RECOVERED IMMEDIATELY AFTER TUBE REPLACEMENT. NO SEQUAELAE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIVONA REDIATRIC FLEXTEND TRACHEOSTOMY TUBE | TRACHEOSTOMY TUBE | BTO | BIVONA MEDICAL TECHNOLOGIES | NA | 917660 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19 MO | Life Threatening| R |