BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIFLO ENTERAL FEEDING TUBE

    MDR report key: 339574 · Received June 22, 2001

    Report

    Report Number
    1528738-2001-00032
    Event Type
    Malfunction
    Date Received
    June 22, 2001
    Date of Event
    April 12, 2001
    Report Date
    May 3, 2001
    Manufacturer
    ROSS PRODUCTS DIVISION/ABBOTT LABORATORIES
    Product Code
    BSS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER STATED THE STYLET WAS PROTRUDING FROM THE DISTAL END OF THE TUBE DURING PLACEMENT. THERE WAS NO ILLNESS, INJURY OR MEDICAL INTERVENTION REPORTED AS RESULTING FROM THE EVENT. ONE PT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28936 FLEXIFLO ENTERAL FEEDING TUBE 78 BSS TUBE, NASOGASTRIC BSS ROSS PRODUCTS DIVISION/ABBOTT LABORATORIES 473 65-163-DT-01

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other