BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIFLO ENTERAL FEEDING TUBE

    MDR report key: 190178 · Received October 1, 1998

    Report

    Report Number
    1528738-1998-00058
    Event Type
    Malfunction
    Date Received
    October 1, 1998
    Date of Event
    September 2, 1998
    Report Date
    September 4, 1998
    Manufacturer
    ABBOTT LABORATORIES/ROSS PRODUCTS DIVISION
    Product Code
    BSS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING TUBE REMOVAL, A LITTLE RESISTANCE WAS NOTED. X-RAY CONFIRMED THE TUBE WAS SPLIT LENGTHWISE. THE PT WAS NOT FED THROUGH THE TUBE. THIS EVENT OCCURRED ON TWO TUBES WITH AN AGITATED PT WHO PULLED ON THE TUBES. THE PT HAD A TOTAL OF THREE TUBE PLACEMENTS. THERE WAS NO ILLNESS, INJURY OR MEDICAL INTERVENTION RESULTING FROM THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIFLO ENTERAL FEEDING TUBE 78 BSS TUBES, NASOGASTRIC BSS ABBOTT LABORATORIES/ROSS PRODUCTS DIVISION 473 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other