BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOMED ORAL DISPENSER

    MDR report key: 5383846 · Received January 15, 2016

    Report

    Report Number
    MW5059484
    Event Type
    Malfunction
    Date Received
    January 15, 2016
    Date of Event
    December 23, 2015
    Report Date
    January 15, 2016
    Manufacturer
    NEOMED INCORPORATED
    Product Code
    KYX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    NEOMED ORAL SYRINGE CAP BROKE OFF INSIDE TIP OF ORAL SYRINGE. BROKEN PLASTIC PIECE FROM CAP IS AT RISK OF THEN BEING ADMINISTERED TO CHILD INADVERTENTLY. WE HAVE HAD 2-3 REPORTS FROM NURSES OF THIS PROBLEM; UNFORTUNATELY ONLY ONE SYRINGE WAS SAVED. IT WILL BE FORWARDED TO THE NEOMED REP. SYRINGE WAS RETURNED TO PHARMACY BECAUSE IT WOULD NOT DELIVER MEDICATION. WE HAVE RECEIVED ADDITIONAL COMPLAINTS ABOUT THE 6ML ORAL SYRINGE, BUT OTHER DEFECTIVE PRODUCTS HAVE NOT BEEN RETURNED TO THE PHARMACY FOR REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28861 NEOMED ORAL DISPENSER ORAL SYRINGE KYX NEOMED INCORPORATED NM-S3EO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK