BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURE

    MDR report key: 11814968 · Received May 12, 2021

    Report

    Report Number
    1937141-2021-00005
    Event Type
    Malfunction
    Date Received
    May 12, 2021
    Report Date
    July 27, 2021
    Manufacturer
    THE METRIX COMPANY
    Product Code
    KPE
    UDI-DI
    50812496011577
    PMA / PMN Number
    K030888
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PARTICULATE WAS FOUND IN 2 TO POSSIBLY 9 UNITS OF THE SECURE 50 ML 2 PORT EVA BAGS, LOT 66043-A6591. LATER IT WAS REPORTED AN ADDITIONAL 9 UNITS WERE IDENTIFIED WITH PARTICULATE. THE PARTICULATE WAS NOTED BY THE SAME PHARMACY UPON INSPECTION AFTER THE BAGS WERE FILLED. THERE IS NO REPORT OF PATIENT INJURY OR DEATH. THE PARTICULATES ARE IN THE PROCESS OF BEING ANALYZED BY A THIRD PARTY LABORATORY. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712209 SECURE 50ML 2 PORT EVA BAG KPE THE METRIX COMPANY 66043 66043-A6591 50812496011577

    Patients

    Seq Age Sex Outcome Treatment
    1