BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENFIT PU FEEDING TUBE

    MDR report key: 24531053 · Received March 6, 2026

    Report

    Report Number
    24531053
    Event Type
    Malfunction
    Date Received
    March 6, 2026
    Date of Event
    February 26, 2026
    Report Date
    March 3, 2026
    Manufacturer
    AVANOS MEDICAL, INC.
    Product Code
    BSS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE PEDS NG [NASOGASTRIC] TUBES HAVE BEEN DIFFICULT OR NEAR IMPOSSIBLE TO CAP. ONCE THE TUBE HAS BEEN PLACED AND TAPED ON THE PATIENT, THE DISTAL END WITH THE SMALL PURPLE CAP DOES NOT FIT WELL INTO THE HOLE TO SEAL IT OFF. THIS HAS LED TO LOSS OF MEDS, FEEDS, ETC. THAT HAVE DRIPPED OUT OF THE LINE. IT APPEARS THAT THE DISTAL CAP BECOMES DEFORMED AFTER EACH USE (UNCAP AND RECAP). MANUFACTURER RESPONSE FOR TUBE, NASOGASTRIC, ENFIT PU FEEDING TUBE (PER SITE REPORTER). AVANOS WAS NOTIFIED ON [REDACTED]. THERE HAS BEEN NO RETURN COMMUNICATION OR ACKNOWLEDGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592344 ENFIT PU FEEDING TUBE TUBE, NASOGASTRIC BSS AVANOS MEDICAL, INC. PFTM8.0P-NC TY250812

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other