FDA Adverse Event
Injury
Summary report: N
BARDEX NASOPHANYNGEAL AIRWAY
MDR report key: 67200
·
Received January 31, 1997
Report
- Report Number
- 67200
- Event Type
- Injury
- Date Received
- January 31, 1997
- Date of Event
- January 17, 1997
- Report Date
- January 24, 1997
- Manufacturer
- *
- Product Code
- BTQ
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- TX, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
NASOPHARYNGEAL AIRWAY INSERTED INTO RT NARE 1/16/97 TO AID IN SUCTIONING. WITHIN 24 HRS AIRWAY UNABLE TO BE LOCATED. SEARCH OF AREA AND PT'S AIRWAY REVEALED NOTHING. O2 SATURATION GOOD. AT APPROX 1200 01/17 PT EXPERIENCED RESPIRATORY DIFFICULTY. ENDOTRACHEAL TUBE INSERTED. CXR DONE FOR POSITIONING. RADIOLOGIST TOLD NURSE TO BACK UP ET TUBE 4 CM. WHEN TUBE BACKED UP F/U CXR REVEALED NASOPHARYNGEAL AIRWAY IN RT MAINSTEM BRONCHUS. PT NOT ABLE TO TOLERATE BRONCHOSCOPY SO TAKEN TO OR, GENERAL ANESTHESIA, AND AIRWAY REMOVED. REMAINED IN ICU, VENTILATED FOR 4 MORE DAYS. WEANED FROM VENT AND SENT TO FLOOR 1/22. TO SKILLED NURSING 1/24. AT THIS TIME RECOVERING FROM ADMISSION DIAGNOSIS OF PNEUMONIA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BARDEX NASOPHANYNGEAL AIRWAY | NASOPHARYNGEAL AIRWAY | BTQ | * | ROBERTAZZI MODEL | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Required Intervention |