BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE SALEM PUMP

    MDR report key: 2237973 · Received September 1, 2011

    Report

    Report Number
    MW5022100
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    August 21, 2011
    Report Date
    September 1, 2011
    Product Code
    BSS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    THE PT'S NASAL FT (SILICONE SALEM PUMP) CLOGGED AFTER ADMINISTRATION OF MORNING DOSE OF LANSOPRAZOLE ODT VIA TUBE. RN WORKED ON IT AND WAS ABLE TO UNCLOG THE TUBE. ABOUT TWO HOURS LATER WITH ANOTHER MED ADMINISTRATION (CALCIUM CITRATE, MV W/ MINERALS), THE TUBE WAS CLOGGED AND UNABLE TO UNCLOG; NURSE TRIED HOT WATER AND (B)(6). THIS REPORT IS CONSISTENT WITH MULTIPLE PRIOR INCIDENTS IN OTHER PTS AT OUR INSTITUTION OF TUBE OCCLUSION SECONDARY TO LANSOPRAZOLE SOLU-TAB ADMINISTRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE SALEM PUMP NASAL FT BSS

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other EXPIRATION DATE: 04/30/2014| LOT# 015852E| FREQUENCY: DAILY| LANSOPRAZOLE 30 MG SANDOZ| DOSE OR AMOUNT: 30 MG| DATES OF USE: (B)(6) 2011| NDC #: (B)(4)