BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXACTAMIX

    MDR report key: 16644166 · Received March 30, 2023

    Report

    Report Number
    1937141-2023-00015
    Event Type
    Malfunction
    Date Received
    March 30, 2023
    Date of Event
    March 6, 2023
    Report Date
    March 30, 2023
    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

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT A PATIENT IDENTIFIED A LEAK IN TWO PARENTERAL NUTRITION BAGS AT THEIR HOME PRIOR TO USE . THE CUSTOMER FURTHER REPORTED "PATIENT REPORTED THEY NOTICED THAT 2 BAGS WERE LEAKING; HOWEVER COULD NOT IDENTIFY THE LOCATION OF THE LEAKS. PATIENT HAD ALREADY DISPOSED OF THE BAGS AND COULD NOT RETRIEVE THEM FOR A PHOTO." THE CUSTOMER WAS UNABLE TO OBTAIN INFORMATION FROM THE PATIENT REGARDING IF ANY SKIN CONTACT WITH THE SPILLED SOLUTION HAD OCCURRED NOR IF ANY DAMAGE WAS OBSERVED TO THE PRODUCT PACKAGING. 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
    567180 EXACTAMIX 3000 ML EMPTY EVA DUAL CHAMBER BAG KPE THE METRIX COMPANY H938905 63630-A7565 00085412477473

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown