BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    16FR CORFLO CUBBY LOW PROFILE FEEDING DEVICE

    MDR report key: 3940953 · Received April 23, 2014

    Report

    Report Number
    3009124963-2014-00011
    Event Type
    Malfunction
    Date Received
    April 23, 2014
    Date of Event
    March 13, 2014
    Report Date
    April 23, 2014
    Manufacturer
    CORPAK MEDSYSTEMS
    Product Code
    KNT
    PMA / PMN Number
    K990127
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED FOR EVALUATION, THE CUSTOMER REPORTED DISCARDING THE SAMPLE. PICTURES OF THE CUBBY SHAFT AS WELL AS THE GASTRIC DEVICE INSERTION SITE WERE RECEIVED. IT WAS DIFFICULT TO CLEARLY VISUALIZE THE CUBBY SHAFT FROM THE PICTURES. THE REPORTED "BALLOON BURST" COULD NOT HAVE HAPPENED AFTER THE SHAFT SEPARATED FROM THE REST OF THE DEVICE SINCE THE INFLATION LINE WOULD HAVE BEEN COMPROMISED CAUSING THE BALLOON TO DEFLATE NOT BURST. IT IS POSSIBLE THAT THE SHAFT CAME IN CONTACT WITH A SHARP OBJECT CAUSING A SMALL CUT, WHICH OVER TIME PROPAGATED INTO A TEAR ULTIMATELY RESULTING IN THE SHAFT SEPARATING FROM THE REST OF THE DEVICE. WITHOUT A SAMPLE, A DEFINITIVE ROOT CAUSE CAN NOT BE DETERMINED.

    Description of Event or Problem · 1

    ON (B)(6), THE CUSTOMER NOTICED LEAKING AROUND THEIR SON'S CUBBY SITE. THE DEVICE HAD BEEN IN SITU FOR 1 MONTH. THE BALLOON WAS CHECKED FOR LEAKING, BUT NONE WAS NOTED. THE CUBBY WAS STILL IN PLACE, HOWEVER, WAS LOOSE. THAT EVENING, IT WAS NOTICED THE BALLOON HAD BURST. THE CUBBY WAS KEPT IN PLACE WITH A BANDAGE UNTIL (B)(6). ON (B)(6), THE SKIN AROUND THE STOMA SITE WAS RED AND VERY TENDER. THE CUSTOMER BROUGHT HER SON ALONG WITH A REPLACEMENT DEVICE TO THE HOSPITAL FOR RE-INSERTION. THE PHYSICIAN INSPECTED THE SITE PRIOR TO A NEW TUBE INSERTION AND NOTICED THAT THE BALLOON PART OF THE CUBBY HAD BROKEN OFF INTO HIS STOMACH AND THE SITE HAD CLOSED. (B)(6) EVENING, THE DEVICE WAS RETRIEVED WITH AN ENDOSCOPE AND THE STOMA RE-OPENED. A GASTROSTOMY TUBE WAS PLACED. PATIENT DEVELOPED SIGNIFICANT PERI-STOMAL EXCORIATION FROM THE LEAKING/BROKEN CUBBY BUTTON WHICH WAS MANAGED WITH DRESSINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245454 16FR CORFLO CUBBY LOW PROFILE FEEDING DEVICE NONE KNT CORPAK MEDSYSTEMS 35-1610 64891

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR