BEUDAMED
    FDA Adverse Event Death Summary report: N

    PEG-24-PULL-S

    MDR report key: 1980301 · Received January 25, 2011

    Report

    Report Number
    1980301
    Event Type
    Death
    Date Received
    January 25, 2011
    Date of Event
    December 28, 2010
    Report Date
    January 25, 2011
    Manufacturer
    COOK MEDICAL ,INC.
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    LAST MONTH, A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG)TUBE WAS INSERTED AFTER THE ULTRASOUND CONFIRMED NO ASCITES WAS SEEN. THE NEXT DAY, THE TUBE FEEDS (TF) BEGUN AT 20ML/HOUR. THE NEXT DAY THE PT COMPLAINED OF BACK PAIN. THE FOLLOWING DAY, A PNEUMOPERITONEUM WAS NOTED. THE NEXT DAY, THE SURGEON EXAMINED THE PT AND A CT AND NOTED A PROBABLE SMALL AIR LEAK AROUND THE TUBE THAT WAS NOT CONSIDERED CLINICALLY SIGNIFICANT. THE TUBE WAS SECURED AND AUTHORIZATION GIVEN TO CONTINUE. THE TF WAS GIVEN. THE FOLLOWING DAY, THE MD WAS CALLED TO SEE THE PT FOR REPORT OF THE PEG LEAKING CLEAR/YELLOWISH FLUID THAT WAS THOUGHT TO BE ASCITES FLUID. THE TF WERE HELD. THE PT'S ABDOMEN WAS DISTENDED ALTHOUGH NO RESIDUALS WERE NOTED. LATER IN THE DAY A LARGE AMOUNT OF CLEAR YELLOW/GREEN FLUID WAS SEEN LEAKING AROUND THE PEG TUBE. THE PT WAS TAKEN TO THE OR EMERGENTLY FOR AN EXPLORATORY LAPAROTOMY AND FOUND TO HAVE PERITONITIS AND A DISLODGED PEG TUBE. THE ABDOMINAL WALL-BUMPER REMAINED IN THE STOMACH. THE PT NOW HAD SEPSIS IN ADDITION TO UNDERLYING CIRRHOSIS, RESPIRATORY FAILURE AND SUBSEQUENT RENAL FAILURE. THE FAMILY WITHDREW CARE AND THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEG-24-PULL-S PEG TUBE KNT COOK MEDICAL ,INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Death| R NO OTHER THERAPIES