BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURE

    MDR report key: 11785688 · Received May 6, 2021

    Report

    Report Number
    1937141-2021-00003
    Event Type
    Malfunction
    Date Received
    May 6, 2021
    Report Date
    May 6, 2021
    Manufacturer
    THE METRIX COMPANY
    Product Code
    KPE
    UDI-DI
    00812496011701
    PMA / PMN Number
    K030888
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED FOR EVALUATION AND CONFIRMED TO CONTAIN A MOBILE RED PARTICLE. THE RED PARTICLE WAS FURTHER ANALYZED BY FTIR METHOD AND THE RESULTS SUGGEST IT COULD BE A POLYMER CONTAINING VINYL ACETATE. A REVIEW OF THE MANUFACTURING AREA SUGGESTS A POTENTIAL SOURCE IS A RED ADHESIVE USED AS THE BINDING ON A TEAR OFF FORM TABLET. A PRODUCTION RECORD REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A RED FOREIGN PARTICLE WAS IDENTIFIED IN AN EMPTY SECURE 500ML EVA CONTAINER WITH MALE SCREW CONNECTOR. THIS WAS DISCOVERED BY A PHARMACY TECHNICIAN PRIOR TO FILLING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683995 SECURE 500 ML EVA CONTAINER WITH MALE SCREW CONNECTOR KPE THE METRIX COMPANY 66210 66210-A6956 00812496011701

    Patients

    Seq Age Sex Outcome Treatment
    1