BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRI FUNNEL 20F G-TUBE

    MDR report key: 3924990 · Received June 17, 2014

    Report

    Report Number
    3006260740-2014-00314
    Event Type
    Death
    Date Received
    June 17, 2014
    Report Date
    April 1, 2014
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    KGC
    PMA / PMN Number
    K910492
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR FOR EVAL, AS THE DEVICE REMAINS IN THE PT. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MFG LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    ON (B)(6) 2014, MY WIFE HAS JUST HAD THE REFERENCED PEG TUBE INSTALLED AS A REPLACEMENT FOR THE ORIGINAL. I HAVE TWO CONCERNS; ONE, I AM UNABLE TO PULL A RESIDUAL TEST ON THE CONTENTS IN HER STOMACH. IS THERE A CHECK VALUE IN THIS TUBE OR IS THIS A MALFUNCTION? THE OTHER IS THAT THE LARGE PORT IS TOO SMALL FOR MY SYRINGE CATHETER. I AM HAVING TO USE A PONSKY PORT FROM ANOTHER TUBE. DO YOU KNOW OF AN EXTENSION THAT I CAN PROCURE THAT WILL FIT YOUR PORT". ON (B)(6) 2014, HE WAS ABLE TO DRAIN A CUP AND A HALF OF FEEDS BY GRAVITY. THE CUSTOMER STATED THAT HE DID REPORT THE ISSUE TO HIS FAMILY PHYSICIAN, AS BAS ADVISED, AND THAT REPLACEMENT WITH A DIFFERENT DEVICE WAS RECOMMENDED BUT HE NEVER SCHEDULED THE DEVICE REPLACEMENT. ON (B)(6) 2014, WIFE DIED ON (B)(6) 2014 AFTER SUFFERING A HORRIBLE EXPERIENCE AS A RESULT ON TOO MUCH OR HER STOMACH BECAUSE I WAS UNABLE TO PULL A RESIDUAL WITH YOUR PEG. ON (B)(6) 2014, CUSTOMER STATED THAT WIFE HAD BULBAR PALSY AND DEATH WAS NOT FROM DEVICE BUT FROM DISEASE. CUSTOMER WAS ABLE TO ADMINISTER TUBE FEEDS WITHOUT DIFFICULTY AND GRAVITY DRAIN FEEDS FROM DEVICE, BUT WHEN SLIGHTEST SUCTION WAS APPLIED, HE FELT THAT THE TUBE COLLAPSED. THE PT WAS UNABLE TO ABSORB TUBE FEEDS AND WAS ON REGULAR DOSES OF REGLAN BUT CONTINUE TO DECLINE. CUSTOMER STATED THAT WIFE PASSED FROM BULBAR PALSY COMPLICATED BY PNEUMONIA. HUSBAND REPORTED INCREASED RESPIRATORY DISTRESS AND CHOKING. THE HUSBAND SUCTIONED THE MOUTH AND THROAT BUT THERE WERE NO GASTRIC CONTENTS PRESENT. PT WAS PLACED ON HOSPICE CARE. UNK IF PNEUMONIA AND RESPIRATORY DISTRESS WAS CAUSED BY ASPIRATION. NO AUTOPSY WILL BE PERFORMED DUE TO DIAGNOSIS OF TERMINAL ILLNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355938 TRI FUNNEL 20F G-TUBE KGC BARD ACCESS SYSTEMS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R