FDA Adverse Event
Malfunction
Summary report: N
HUDSON ENDOTRACHEAL TUBE, HVT, 7.0, NOVA PLUS
MDR report key: 3063608
·
Received April 12, 2013
Report
- Report Number
- 3003898360-2013-00133
- Event Type
- Malfunction
- Date Received
- April 12, 2013
- Date of Event
- March 18, 2013
- Report Date
- March 25, 2013
- Manufacturer
- TELEFLEX
- Product Code
- BTR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND THERE WERE NO ISSUES FOUND THAT COULD RELATE TO THE REPORTED COMPLAINT. THE SAMPLE WAS NOT RETURNED FOR EVALUATION, THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED.
Description of Event or Problem · 1
THE COMPLAINT IS REPORTED AS: DURING VENTILATION ON A PATIENT THE HUB DISCONNECTED FROM THE ET TUBE AND WOULDN'T STAY IN PLACE. IT HAD TO BE TAPED DOWN. NO PT INJURY REPORTED. PT CONDITION IS LISTED AS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 157069 | HUDSON ENDOTRACHEAL TUBE, HVT, 7.0, NOVA PLUS | ET TUBE | BTR | TELEFLEX | 01H1200169 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |