BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVA DUAL CHAMBER CONTAINER 3L

    MDR report key: 8016206 · Received October 29, 2018

    Report

    Report Number
    1416980-2018-06919
    Event Type
    Malfunction
    Date Received
    October 29, 2018
    Report Date
    February 5, 2019
    Manufacturer
    THE METRIX COMPANY
    Product Code
    KPE
    UDI-DI
    00085412477473
    PMA / PMN Number
    K960581
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS IN PROGRESS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION : THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, A COMPANION SAMPLE WAS RECEIVED AND EVALUATED. BOTH FILL PORT CAPS ON THE DEVICE WERE REMOVED WITH ANY DIFFICULTY. A VISUAL INSPECTION OF THE THREADS WAS PERFORMED ON BOTH FILL PORTS AND NO DAMAGE WAS OBSERVED ON EITHER PORT. BOTH FILL PORT CAPS WERE EASILY REMOVED AND THREADED BACK ON WITHOUT ANY DIFFICULTY AND TWISTING THE CAP WAS NOT DIFFICULT ON EITHER PORT. THE REPORTED ISSUES WERE NOT VERIFIED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN EXACTAMIX 3000 ML DUAL-CHAMBER EVA (ETHYL VINYL ACETATE) BAG WAS VERY HARD TO SPIKE AND TWISTING THE CAP WAS VERY DIFFICULT. THIS WAS NOTICED DURING SET-UP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856321 EVA DUAL CHAMBER CONTAINER 3L CONTAINER, I.V. KPE THE METRIX COMPANY NA 63630-A2649 00085412477473

    Patients

    Seq Age Sex Outcome Treatment
    1