BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXACTAMIX

    MDR report key: 11998708 · Received June 15, 2021

    Report

    Report Number
    1937141-2021-00011
    Event Type
    Malfunction
    Date Received
    June 15, 2021
    Date of Event
    May 25, 2021
    Report Date
    June 15, 2021
    Manufacturer
    THE METRIX COMPANY
    Product Code
    KPE
    UDI-DI
    00085412477473
    PMA / PMN Number
    K960581
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    A PHOTOGRAPH WAS PROVIDED; HOWEVER, THE ACTUAL BAG IS NOT VISIBLE IN THE PHOTOGRAPH. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SINGLE UNIT OF AN EXACTAMIX 3000 ML DUAL CHAMBER EVA BAG WAS FOUND TO BE LEAKING UPON ARRIVAL AT A PATIENT'S HOME. THE LEAK WAS IDENTIFIED PRIOR TO USE AND THE ACTUAL SAMPLE WAS DISCARDED BY THE CUSTOMER. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    902668 EXACTAMIX 3000 ML EMPTY EVA DUAL CHAMBER BAG KPE THE METRIX COMPANY H938905 63630-A5973 00085412477473

    Patients

    Seq Age Sex Outcome Treatment
    1