FDA Adverse Event
Summary report: N
ENDOTRACHEAL TUBE
MDR report key: 27432
·
Received October 10, 1995
Report
- Report Number
- MW4000863
- Date Received
- October 10, 1995
- Date of Event
- November 10, 1994
- Report Date
- August 18, 1995
- Manufacturer
- SHERIDAN CATHETER, CORP.
- Product Code
- BTR
- Report Source
- Voluntary report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PT IS A 68 YEAR OLD MALE WHO PRESENTED TO ER WITH DIFFICULTY BREATHING, DIAPHORESIS AND RALES BILATERALLY. MD INTUBATED PT, PT COUGHING, TUBE REMOVED, REINSERTED BY CRNA WITH DIFFICULTY. ER RN STATES ENDOTRACHEAL INTUBATION TUBE DEFECTIVE; WOULD NOT STAY INFLATED. CXR CARDIOMEGALLY WITH MODERATED SEVERE PULMONARY EDEMA AND BILATERAL PLEURAL EFFUSIONS. PT SUCCESSFULLY INTUBATED. NO HARM TO PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTRACHEAL TUBE | ENDOTRACHEAL TUBE | BTR | SHERIDAN CATHETER, CORP. | 020731 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR |