BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX¿

    MDR report key: 8433674 · Received March 19, 2019

    Report

    Report Number
    9681240-2019-00008
    Event Type
    Malfunction
    Date Received
    March 19, 2019
    Date of Event
    February 22, 2019
    Report Date
    April 11, 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
    MA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2013017. B. BRAUN INC. (BBMI) (IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF B. BRAUN ITALY S.P.A. (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). ONE (1) UNUSED BAG WAS RECEIVED FOR EVALUATION. UPON VISUAL EXAMINATION, A BAG DEFORMITY THAT IS PURELY AESTHETIC AND WOULD NOT COMPROMISE THE BAG IN ANYWAY WAS DETECTED. NO PARTICULATE MATTER WAS FOUND INSIDE THE BAG, OR IN THE FLUID PATH. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2013017 B. BRAUN INC. (BBMI) (IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF B. BRAUN ITALY S.P.A. (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION INTO THIS REPORTED EVENT IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE RESULTS OF THE INVESTIGATION ARE AVAILABLE.

    Description of Event or Problem · 0

    AS REPORTED BY USER FACILITY: A 2000 ML SINGLE CHAMBER FINAL CONTAINER FOUND TO HAVE A PARTICLE INSIDE THE BAG DURING THE INITIAL INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225709 APEX¿ CONTAINER, I.V. KPE B. BRAUN AVITUM ITALY S.P.A. 2112531 18H29 04046964539206

    Patients

    Seq Age Sex Outcome Treatment
    1