BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALL-FILL

    MDR report key: 6039466 · Received October 17, 2016

    Report

    Report Number
    MW5065483
    Event Type
    Malfunction
    Date Received
    October 17, 2016
    Date of Event
    October 11, 2016
    Report Date
    October 17, 2016
    Manufacturer
    ALL-FILL INC.
    Product Code
    NXB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WE HAVE BEEN OPERATING A PIECE OF EQUIPMENT CALLED ALL FILL THAT OPERATES AND FILLS POWDER INTO A BOTTLE. THE EQUIPMENT HAS BEEN HAVING THE ISSUE OF PASSING BAD BOTTLES. THE EQUIPMENT SHOULD NOTIFY THE OPERATOR IF A BOTTLE IS OUT OF WEIGHT SPECIFICATIONS WITH A RED LIGHT AND A GREEN LIGHT IF IT IS GOOD. WE HAVE CAUGHT ON 4 SEPARATE OCCASIONS THAT THE EQUIPMENT IS PASSING BOTTLES 1 GRAM HEAVIER THAN SPECIFICATIONS WITH A GREEN LIGHT. MANAGEMENT HAS DONE NO CORRECTIVE ACTION TO THE EQUIPMENT TO FIX THE ISSUE AND QUITE POSSIBLY GIVING PATIENTS A BAD PRODUCT OR STRONGER DOSAGE THEN WHAT IS ON THE LABEL. NAME OF THE PRODUCT AS IT APPEARS ON THE BOX, BOTTLE, OR PACKAGE: FLUCONAZOLE FOR ORAL SUSPENSION. NAME OF THE COMPANY THAT MAKES (OR COMPOUNDS) THE PRODUCT: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686630 ALL-FILL MEDICATION DISPENSER NXB ALL-FILL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1