BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLEXIFLO ENTERAL FEEDING TUBE

    MDR report key: 137924 · Received December 11, 1997

    Report

    Report Number
    137924
    Event Type
    Death
    Date Received
    December 11, 1997
    Date of Event
    December 6, 1997
    Report Date
    December 10, 1997
    Manufacturer
    ROSS LABORATORIES
    Product Code
    BSS
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT W/ALZHEIMER'S DEMENTIA ADMITTED W/FRACTURED HIP. UNABLE TO SWALLOW AND HANDLE SECRETIONS. FEEDING TUBE ORDERED FOR FLUIDS AND MEDS. 12 FR FLEXIFLO TUBE INSERTED THRU RIGHT NOSTRIL PER PACKAGE DIRECTIVES AT 1015. INSERTION EASY, NO RESISTANCE. RN UNABLE TO ASPIRATE GASTRIC FLUID, UNABLE TO HEAR INJECTED AIR. TUBE PULLED BACK, MET RESISTANCE, AND PT REACTED AS IF IN PAIN. TUBE REMOVED WITH STEADY PULL - TRUE KNOT AND A CRIMP NOTED, STYLET PROTRUDING FROM TUBING, 1 INCH ABOVE WEIGHTED BOLUS. PT'S THROAT BLEEDING, CLOT REMOVED BY DR. ESTIMATE 15 SECONDS WITHOUT RESPIRATION. 1045 VITAL SIGNS AND RESPIRATORY RATE STABLE THERE AFTER. AT 1700 ON 12/6/97 PT DEVELOPED INCREASING RESPIRATORY DISTRESS, DNR WISHES FOLLOWED, DIED @ 2055. - MEDICAL EXAMINER STATES CAUSE OF DEATH AS HEMORRHAGIC OROPHARYNX OBSTRUCTION RELATED TO DOBHOFF FEEDING TUBE GUIDEWIRE INJURY TO PHARYNX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIFLO ENTERAL FEEDING TUBE FEEDING TUBE BSS ROSS LABORATORIES * *

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death