BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVIDIEN

    MDR report key: 24895826 · Received April 16, 2026

    Report

    Report Number
    1423537-2026-00111
    Event Type
    Malfunction
    Date Received
    April 16, 2026
    Date of Event
    February 10, 2026
    Report Date
    May 20, 2026
    Manufacturer
    CARDINAL HEALTH, INC.
    Product Code
    PIF
    UDI-DI
    10884521661738
    PMA / PMN Number
    K180622
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PRODUCT CODE: KNT. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THEIR CLIENT TOLD THEM THAT THE GASTROSTOMY TUBE BALLOON DEFLATES AND THE BALLOON HAS TO BE FILLED CONSTANTLY. THE FOOD COMES OUT ON SEVERAL OCCASIONS AS A RESULT OF WHAT HAPPENED. PER ADDITIONAL INFORMATION RECEIVED, THE AFFECTED G-TUBE WAS REPLACED WITH A NEW ONE TO RESOLVE THE ISSUE. AS REPORTED: SOLICITO DE SU APOYO DE URGENCIA, YA QUE CLIENTE NOS COMENTO QUE DE LA SONDA DE GASTROSTOMÍA DE CÓDIGO 8884720247E EL GLOBO SE DESINFLA Y SE TIENE QUE ESTAR LLENANDO EL GLOBO CONSTANTEMENTE. LA COMIDA SE SALE EN VARIAS OCASIONES POR CONSECUENCIA DE LO SUCEDIDO. ENGLISH TRANSLATION: I REQUEST YOUR EMERGENCY SUPPORT, SINCE THE CLIENT TOLD US THAT FROM THE GASTROSTOMY TUBE CODE 8884720247E THE BALLOON DEFLATES AND THE BALLOON HAS TO BE FILLED CONSTANTLY. THE FOOD COMES OUT ON SEVERAL OCCASIONS AS A RESULT OF WHAT HAPPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569009 COVIDIEN GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS PIF CARDINAL HEALTH, INC. 8884720247E 2411010564 10884521661738

    Patients

    Seq Age Sex Outcome Treatment
    1