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