FDA Adverse Event
Malfunction
Summary report: N
RUSCH ADJUSTABLE FLANGE NASAL AIRWAY
MDR report key: 1190760
·
Received October 6, 2008
Report
- Report Number
- 8040412-2008-00012
- Event Type
- Malfunction
- Date Received
- October 6, 2008
- Report Date
- September 16, 2008
- Product Code
- BTQ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
DEVICE REQUESTED BUT HAS NOT BEEN RECEIVED YET. INVESTIGATION IS ONGOING, AND A FOLLOW UP REPORT WILL BE SENT AS SOON AS IS FINISHED.
Description of Event or Problem · 1
INCIDENT DESCRIBES AS : HOSPITAL HAD PROBLEMS WITH NASAL AIRWAY. THE FLANGE IS DESCRIBED AS TOO FLEXIBLE AND CAN BE EASILY DISLODGED INTO THE UPPER AIRWAY. THIS HAPPENED FOUR SEPARATE TIMES DURING INTUBATION. NO ADVERSE OUTCOMES REPORTED. THIS IS THE FIRST OF FOUR REPORTS FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RUSCH ADJUSTABLE FLANGE NASAL AIRWAY | NASAL PHARYNGEAL AIRWAY | BTQ | 07F04 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |