BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTRACARE ULTRAFLO

    MDR report key: 3471 · Received April 14, 1993

    Report

    Report Number
    1819504-1993-00001
    Event Type
    Injury
    Date Received
    April 14, 1993
    Date of Event
    December 26, 1992
    Report Date
    March 4, 1993
    Manufacturer
    ENTECH, INC.
    Product Code
    FPD
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    LA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    NURSE EDUCATOR RELAYS AN ICU RN INSERTED AN ENTRACARE ULTRAFLO NASOGASTRIC FEED IN TUBE INTO THE TRACHEA DOWN THE LEFT MAINSTEM BRONCHUS RESULTING IN A 30 -40% PNEUMOTHORAX REQUIRING CHEST TUBE INSERTION. THE RN WAS UNABLE TO OBTAIN GASTRIC ASPIRATE. TWO X-RAYS WERE DONE AND THE NG TUBE WAS ADVANCED ONCE OVER AN 8 HOUR PERIOD. NO NUTRITIONAL PRUDUCT WAS INSTILLED INTO THE TUBE. THE PATIENT WAS 88 YEARS OLD, A "NO CODE BLUE STATUS, AND WAS REPORTED TOBE UNCONSCIOUS WITH NO GAG REFLEX PRIOR TO INSERTION OF THE NG TUBE. SHE ALSO HAD A NASOPHARYNGEAL AIRWAY IN PLACE AND A 100% NRB OXYGEN MASK. AT THE TIME THE PNEUMOTHORAX WAS DIAGNOSED, THE NG TUBE WAS REMOVED AND DISCARDED. THE PATIENT EXPIRED AT AN UNKNOWN DATEDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: DEVICE DISCARDED. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTRACARE ULTRAFLO NASOGASTRIC FEEDING TUBE FPD ENTECH, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention