BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SALEM SUMP

    MDR report key: 6263277 · Received January 19, 2017

    Report

    Report Number
    6263277
    Event Type
    Malfunction
    Date Received
    January 19, 2017
    Date of Event
    January 16, 2017
    Report Date
    January 18, 2017
    Manufacturer
    COVIDIEN LP
    Product Code
    FEG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NURSE CLAMPED NGT AFTER ADMINISTERING CRUSHED MEDICATIONS WITH THE WHITE END OF THE ANTI-REFLUX VALVE INSERTED INTO THE BLUE SUMP PART OF THE NGT. WHEN NURSE WENT TO UNCLAMP THE NGT, THE WHITE PART BROKE OFF OF THE BLUE END OF THE VALVE AND REMAINED STUCK INSIDE THE CLEAR PORTION OF THE NGT. IT TOOK OVER 10 MINUTES TO DIG THE STUCK PART BACK OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47309 SALEM SUMP TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION FEG COVIDIEN LP 266148

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR