BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX¿

    MDR report key: 8666458 · Received June 4, 2019

    Report

    Report Number
    9681240-2019-00025
    Event Type
    Malfunction
    Date Received
    June 4, 2019
    Report Date
    July 29, 2019
    Manufacturer
    B. BRAUN AVITUM ITALY S.P.A.
    Product Code
    KPE
    UDI-DI
    04046964539206
    PMA / PMN Number
    K041415
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS EVENT SIX OF B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). THREE (3) COMPOUNDED BAGS WERE RECEIVED FOR EVALUATION. WHEN THE COMPOUNDED SOLUTION WAS FILTERED, A PARTICLE OF 0.2 TO 0.3 MM DIAMETER WAS FOUND IN ONE OF THE BAGS, THE OTHER TWO BAGS DID NOT HAVE ANY PARTICULATE PRESENT. THIS PARTICLE WAS TOO SMALL TO ANALYZE UNDER FT-IR ANALYSIS, SO THE EXACT SUBSTANCE COULD NOT BE IDENTIFIED. THERE WERE NO PRODUCT DEVIATIONS, AND THE PARTICLE COULD NOT BE ATTRIBUTED TO THE PRODUCTION PROCESS. SINCE THE BAG HAD BEEN FILLED, IT IS POSSIBLE THAT THE CONTAMINATION OCCURRED DURING THE FILLING PROCESS. REVIEW OF THE DEVICE HISTORY RECORD PERFORMED FOR THE REPORTED LOT NUMBER DID NOT REVEAL ANY ABNORMALITIES OR NONCONFORMANCES OF THIS NATURE. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION INTO THIS REPORTED EVENT IS ONGOING. ADDITIONAL ATTEMPTS TO RECEIVE THE SAMPLE ARE BEING MADE. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE RESULTS OF THE INVESTIGATION ARE AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY USER FACILITY: EVENT 6: 'CORES' FOUND AFTER COMPOUNDING, DURING FINAL INSPECTIONS. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461614 APEX¿ CONTAINER, I.V. KPE B. BRAUN AVITUM ITALY S.P.A. 2112531 18I12 04046964539206

    Patients

    Seq Age Sex Outcome Treatment
    1