BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORFLO CUBBY LOW PROFIILE GASTROSTOMY DEVICE

    MDR report key: 1059976 · Received June 12, 2008

    Report

    Report Number
    3005099803-2008-00682
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    May 13, 2008
    Report Date
    May 13, 2008
    Manufacturer
    KABUSHIKI KAISHA JSS
    Product Code
    KNT
    PMA / PMN Number
    K990127
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE AND THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED. THE 2008 15-MONTH LOW PROFILE BALLOON ENTERAL FEEDING PRODUCT FAMILY TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED, NO UNFAVORABLE TREND WAS NOTED.

    Description of Event or Problem · 1

    A CORFLO CUBBY LOW PROFILE GASTROSTOMY DEVICE WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY REPLACEMENT PROCEDURE IN 2008, (PATIENT GENDER, AGE AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, "STERILIZED WATER WAS INJECTED [INTO] THE BALLOON PROPERLY. HOWEVER, THE BALLOON... CAME OFF OUTSIDE THE [PATIENT'S] BODY WHEN THE RIGHT ANGLE TUBE WAS CONNECTED 4 DAYS AFTER PLACEMENT". REPORTEDLY, THE PHYSICIAN REMOVED THE DEVICE AND COMPLETED THE PROCEDURE WITH A DIFFERENT DEVICE (UNKNOWN PRODUCT AND MANUFACTURER). NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORFLO CUBBY LOW PROFIILE GASTROSTOMY DEVICE KNT KABUSHIKI KAISHA JSS M00581080 0000028865

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK