BEUDAMED
    FDA Adverse Event Other Summary report: N

    DAVOL NASOGASTRIC SUMP TB

    MDR report key: 121326 · Received September 18, 1997

    Report

    Report Number
    1018233-1997-00049
    Event Type
    Other
    Date Received
    September 18, 1997
    Report Date
    September 18, 1997
    Manufacturer
    C.R. BARD, INC.
    Product Code
    FEG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SUMP TUBE BACKED UP AND NEEDED TO BE CLEARED THROUGH THE AIR VENT. NURSING PERSONNEL WERE NOT FAMILIAR WITH PRODUCT OR HOW TO CLEAR THROUGH AIR VENT. PRODUCT WAS REMOVED AND REPLACED AND 400 CC OF BILE WAS SUCTIONED FROM PT. DURING THIS PERIOD, THE PT'S STOMACH BECAME DISTENTED CAUSING BREAKAGE OF SURGICAL SUTURES. PT TAKEN TO O.R. FOR SURGICAL REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAVOL NASOGASTRIC SUMP TB NG TUBE W/ANTIREFLUX FIL FEG C.R. BARD, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other