BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXACTAMIX

    MDR report key: 12908360 · Received December 1, 2021

    Report

    Report Number
    1937141-2021-00020
    Event Type
    Malfunction
    Date Received
    December 1, 2021
    Date of Event
    November 1, 2021
    Report Date
    December 1, 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 · 0

    THE ACTUAL SAMPLES WERE DISCARDED BY THE CUSTOMER. NO PHOTOGRAPHS WERE AVAILABLE. THE CUSTOMER PROVIDED A DIAGRAM INDICATING THE LEAK WAS LOCATED BELOW THE ROD/CHANNEL AREA ON THE RIGHT SIDE OF THE FACE OF THE BAG. THE CUSTOMER WAS NOT AWARE OF ANY DAMAGE TO THE PRODUCT, POUCH OR CARTON. TWO EMPTY SAMPLES FROM THE SAME LOT WERE RETURNED FOR EVALUATION AND NO LEAKS WERE IDENTIFIED UPON TESTING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TWO UNITS OF AN EXACTAMIX DUAL CHAMBER BAG WERE FOUND TO BE LEAKING. THE LEAK WAS IDENTIFIED PRIOR TO REMOVAL OF THE ROD AND CHANNEL SEPARATING THE CHAMBERS. THE LEAK WAS IDENTIFIED PRIOR TO PATIENT USE. 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
    1804574 EXACTAMIX 3000 ML EMPTY EVA DUAL CHAMBER BAG KPE THE METRIX COMPANY H938905 63630-A7036 00085412477473

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown