BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURE

    MDR report key: 11901240 · Received May 28, 2021

    Report

    Report Number
    1937141-2021-00007
    Event Type
    Malfunction
    Date Received
    May 28, 2021
    Report Date
    July 28, 2021
    Manufacturer
    THE METRIX COMPANY
    Product Code
    KPE
    UDI-DI
    20812496011859
    PMA / PMN Number
    K843523
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNITS HAVE BEEN SUBMITTED TO AN EXTERNAL LABORATORY FOR EVALUATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PARTICULATE WAS FOUND IN 8 UNITS OF SECURE 100 ML 2 PORT PVC BAGS. THE PARTICULATE WAS NOTED BY THE PHARMACY UPON INSPECTION AFTER THE BAGS WERE FILLED WITH VASOPRESSIN. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801518 SECURE 100 ML 2 PORT PVC BAG KPE THE METRIX COMPANY 58719 58719-31595 20812496011859

    Patients

    Seq Age Sex Outcome Treatment
    1