BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENFAMIL SLOW-FLOW SOFT NIPPLE

    MDR report key: 24887997 · Received April 15, 2026

    Report

    Report Number
    MW5186854
    Event Type
    Malfunction
    Date Received
    April 15, 2026
    Report Date
    February 4, 2026
    Manufacturer
    NUK USA LLC.
    Product Code
    FNN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    UPON OPENING THE PACKAGE OF A BABY BOTTLE NIPPLE, STAFF NOTED A BLACK SUBSTANCE ON THE INSIDE THE NIPPLE. IT DID NOT REACH A PATIENT. THE PACKAGING WAS INTACT WITH NO OBVIOUS BREACH TO THE INTEGRITY OF IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948864 ENFAMIL SLOW-FLOW SOFT NIPPLE NIPPLE, LAMBS FEEDING FNN NUK USA LLC. 4339-17 0000426668

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown