BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERAL FEEDING

    MDR report key: 13860353 · Received March 23, 2022

    Report

    Report Number
    13860353
    Event Type
    Malfunction
    Date Received
    March 23, 2022
    Date of Event
    February 12, 2022
    Report Date
    March 15, 2022
    Manufacturer
    MEDELA LLC
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FROM 2/12/2022-3/4/2022, THERE WERE 13 REPORTED NASOGASTRIC TUBES THAT WERE NOTED TO BE CRACKED AND LEAKING. THIS REQUIRED THE TUBES TO BE PLACED. THE AFFECTED LOT#'S ARE: 211142; 210953; 211169.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1128977 ENTERAL FEEDING TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT MEDELA LLC ENPU2065 211142, 210953, 211169

    Patients

    Seq Age Sex Outcome Treatment
    1 60 DA Female