BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORFLO CUBBY DUAL PORT STANDARD BALLOON

    MDR report key: 1161364 · Received September 12, 2008

    Report

    Report Number
    3005099803-2008-04532
    Event Type
    Malfunction
    Date Received
    September 12, 2008
    Date of Event
    August 13, 2008
    Report Date
    August 14, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE MANUFACTURE DATE IS UNK. ALTHOUGH THE COMPLAINANT HAS INDICATED THAT THE SUSPECT DEVICE IS BEING RETURNED FOR EVALUATION, IT HAS NOT BEEN RECEIVED. THE DEVICE EVALUATION HAS NOT BEEN PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP IN 2008, THAT A CORFLO CUBBY DUAL PORT STANDARD BALLOON DEVICE WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) REPLACEMENT PROCEDURE. ACCORDING TO THE COMPLAINANT, WHEN THE DEVICE WAS PLACED, "NUTRITION WAS OBSERVED LEAKING AROUND THE CLOSED FEEDING PORT." THE PROCEDURE WAS COMPLETED WITH ANOTHER CORFLO CUBBY DUAL PORT STANDARD BALLOON DEVICE. THERE WERE NO PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORFLO CUBBY DUAL PORT STANDARD BALLOON KNT BOSTON SCIENTIFIC CORPORATION M00581420 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK