BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX¿

    MDR report key: 8570839 · Received May 1, 2019

    Report

    Report Number
    9681240-2019-00013
    Event Type
    Malfunction
    Date Received
    May 1, 2019
    Date of Event
    April 15, 2019
    Report Date
    June 26, 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
    CO, 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 BAG WAS RECEIVED FOR EVALUATION. UPON VISUAL INSPECTION BY THE NAKED EYE, ONE PARTICLE WAS DETECTED. THIS PARTICLE WAS IDENTIFIED AS ACRYLONITRILE BUTADIENE STYRENE (ABS) UNDER FT-IR ANALYSIS. THERE IS A COMPONENT OF THE BAG ASSEMBLY THAT IS MADE FROM ABS. AS A RESULT, THE COMPONENT OF THE BAG MADE FROM ABS COULD NOT BE EXCLUDED AS THE SOURCE OF THE CONTAMINATION. THE COMPONENT CONTAINING ABS IS PURCHASED FROM AN APPROVED SUPPLIER AND GOES THROUGH AN INCOMING INSPECTION BEFORE BEING USED IN PRODUCTION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE COMPONENT GOING BACK TWO YEARS, AND THIS REVIEW DID NOT REVEAL ANY ABNORMALITIES OR NON-CONFORMANCES. THE SUPPLIER OF THE COMPONENT WAS NOTIFIED OF THIS REPORT. A PROJECT HAS BEEN INITIATED TO ADDRESS ISSUES INVOLVING THIS COMPONENT. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE FILED.

    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). 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: FINAL CONTAINER HAD A "WHITE PLASTIC SLIVER" INSIDE. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362978 APEX¿ CONTAINER, I.V. KPE B. BRAUN AVITUM ITALY S.P.A. 2112531 18I19 04046964539206

    Patients

    Seq Age Sex Outcome Treatment
    1