BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIC GJ TUBE

    MDR report key: 7352171 · Received March 20, 2018

    Report

    Report Number
    7352171
    Event Type
    Malfunction
    Date Received
    March 20, 2018
    Date of Event
    February 28, 2018
    Report Date
    March 13, 2018
    Manufacturer
    HALYARD HEALTH, INC.
    Product Code
    KGC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING ELEMENTS HAVE BLANK DATA.

    Description of Event or Problem · 0

    A PATIENT WHO IS PEG-J (PERCUTANEOUS ENDOSCOPIC TRANSGASTRIC JEJUNOSTOMY) TUBE-DEPENDENT UNDERWENT MULTIPLE CHANGE-OUTS TO HIS GASTRO- JEJUNOSTOMY FEEDING TUBE DUE TO CLOGGING. THE PATIENT WAS ONLY RECEIVING GLUCERNA (ABBOTT) THROUGH THE TUBE, FLUSHED AFTERWARDS. SINCE [DATE REDACTED], THE PATIENT HAS HAD A GJ TUBE IN PLACE THAT HAS REQUIRED REMOVAL AND REPLACEMENT 8 TIMES. IT WAS CHANGED 8X OVER TWO MONTHS.

    Description of Event or Problem · 1

    A PATIENT WHO IS PEG-J (PERCUTANEOUS ENDOSCOPIC TRANSGASTRIC JEJUNOSTOMY) TUBE-DEPENDENT UNDERWENT MULTIPLE CHANGE-OUTS TO HIS GASTRO- JEJUNOSTOMY FEEDING TUBE DUE TO CLOGGING. THE PATIENT WAS ONLY RECEIVING GLUCERNA (ABBOTT) THROUGH THE TUBE, FLUSHED AFTERWARDS. SINCE [DATE REDACTED], THE PATIENT HAS HAD A GJ TUBE IN PLACE THAT HAS REQUIRED REMOVAL AND REPLACEMENT 8 TIMES. IT WAS CHANGED 8X OVER TWO MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199062 MIC GJ TUBE TUBE, GASTRO-ENTEROSTOMY KGC HALYARD HEALTH, INC. 95487 AA7348N09

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR