BEUDAMED
    FDA Adverse Event Death Summary report: N

    BARD NASOGASTRIC SUMP TUBE

    MDR report key: 792919 · Received December 7, 2006

    Report

    Report Number
    1018233-2006-00209
    Event Type
    Death
    Date Received
    December 7, 2006
    Report Date
    December 7, 2006
    Manufacturer
    C.R. BARD, INC.
    Product Code
    FEG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO LOT NUMBER INFO WAS PROVIDED FOR EVALUATION. A REVIEW OF THE COMPLAINT HISTORY SHOWED THERE WERE NO PREVIOUS REPORTS OF THIS TYPE RECEIVED FROM THE USER FACILITY AND NO OTHER REPORTS OF DEATHS ASSOCIATED WITH THIS DEVICE HAD BEEN REPORTED. NG TUBES AND THE SUBSEQUENT ASPIRATION OF GASTRIC CONTENTS HAVE BEEN RECOGNIZED AS A RISK FACTOR FOR VENTILATOR ASSOCIATED PNEUMONIA. A RECENT STUDY BY METHANY, ET AL WAS EXECUTED TO DETERMINE THE OCCURRENCE OF ASPIRATION IN PTS RECEIVING NG TUBES AND SMALL BOWEL FEEDING TUBES. THIS STUDY INVOLVING 360 ADULT PTS RECEIVING MECHANICAL VENTILATION AND TUBE FEEDINGS WAS CONDUCTED OVER A TWO-YEAR PERIOD. OVER 5800 TRACHEAL SECRETIONS WERE COLLECTED AND ASSAYED FOR PEPSIN IN WHICH 31.3% OF ALL SAMPLES COLLECTED WERE POSITIVE. ADDITIONALLY, 88.9% OF THE PARTICIPANTS (N=320) EXPERIENCED AT LEAST ONE ASPIRATION EVENT DURING THE STUDY. SEVERAL RISK FACTORS WERE IDENTIFIED FOR ASPIRATION: ANGLE OF BED, LEVEL OF CONSCIOUSNESS, LEVEL OF SEDATION, FEEDING TUBE SITE, GASTRIC RESIDUAL VOLUME, AND VOMITING. IN SUMMARY, ASPIRATION OF GASTRIC CONTENTS IS COMMON IN CRITICALLY ILL PTS AND IS RECOGNIZED AS A MAJOR RISK FACTOR FOR PNEUMONIA. A REVIEW OF THE PRODUCT LABELING SHOWED A WARNING THAT STATED: CHECK ROUTINELY FOR REFLUX IN THE VENT LUMEN OF THE NASOGASTRIC TUBE. THIS INDICATES AN OBSTRUCTED SUCTION LUMEN. FAILURE TO EITHER CLEAR THE OBSTRUCTION, THE LUMEN OR CLEAR THE PREVENT FILTER MAY CAUSE GAS AND FLUID BUILDUP IN THE STOMACH. THIS MAY LEAD TO ASPIRATION OF GASTRIC CONTENTS, POSSIBLY RESULTING IN ASPIRATION PNEUMONIA AND OTHER COMPLICATIONS. A COPY OF THE LABELING IS INCLUDED. BASELINE REPORT PREVIOUSLY FILED FOR THIS PRODUCT FAMILY.

    Description of Event or Problem · 1

    AT A RECENT TRAUMA SYMPOSIUM, A CHIEF OF TRAUMA FROM A LOCAL HOSPITAL REPORTED AN EVENT WHERE A SICU PT IN HIS HOSPITAL PASSED AWAY RECENTLY DUE TO ASPIRATION PNEUMONIA. THE SALEM SUMP NG TUBE WAS IN PLACE WHEN THE PT DIED. THE DOCTOR FELT THAT THE TUBE PLAYED A ROLE IN THE PT'S DEATH BECAUSE THE VENT LUMEN WAS ENTIRELY FULL AND DID NOT ALLOW FOR STOMACH DECOMPRESSION. THE DOCTOR WAS NOT AT ALL BLAMING THE TUBE AND FULLY UNDERSTOOD THE ROLE AND BENEFIT OF THE TUBE. HE KNEW THAT THE VENT LUMEN NEEDS TO BE CHECKED REGULARLY FOR REFLUX AND CLEARED WHEN REFLUX WAS PRESENT TO ALLOW FOR MAXIMUM BENEFIT. HE WAS UPSET WITH THE FACT THAT HIS NURSING STAFF IGNORES IN SERVICING TO SUCH AN EXTENT. HE WENT SO FAR AS TO ADMIT THAT ANYTIME HE SAW ONE OF THESE ON A PT, HE WOULD PULL THE FILTER OFF AND STATED HE WOULD RATHER SEE THE REFLUX GET ON THE BED AND PT RATHER THAN HAVING THE VALVE CLOG AND PREVENT STOMACH DECOMPRESSION. ADD'L INFO HAS BEEN REQUESTED, BUT HAS NOT BEEN RECEIVED. NO REPORT OF THIS EVENT WAS PREVIOUSLY FILED BY THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD NASOGASTRIC SUMP TUBE NASOGASTRIC SUMP TUBE FEG C.R. BARD, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death