BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX¿

    MDR report key: 7868261 · Received September 12, 2018

    Report

    Report Number
    9681240-2018-00012
    Event Type
    Malfunction
    Date Received
    September 12, 2018
    Date of Event
    August 27, 2018
    Report Date
    January 9, 2019
    Manufacturer
    B. BRAUN AVITUM ITALY S.P.A.
    Product Code
    KPE
    UDI-DI
    04046964539121
    PMA / PMN Number
    K041415
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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).. THE INVESTIGATION INTO THIS REPORTED EVENT IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE RESULTS OF THE INVESTIGATION ARE AVAILABLE.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2013017. (B)(6) (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 FILLED BAG WAS RECEIVED FOR EVALUATION. UPON VISUAL INSPECTION BY THE NAKED EYE, IT WAS NOT POSSIBLE TO DETECT ANY FOREIGN MATERIAL. HOWEVER WHEN THE SOLUTION WAS FILTERED A 4 MM LONG TRANSPARENT FILAMENT WAS FOUND. THIS PARTICLE WAS IDENTIFIED AS POLYCARBONATE UNDER FT-IR ANALYSIS. THIS MATERIAL IS NOT PRESENT IN ANY OF THE COMPONENTS OF THE BAG, AND NO SOURCE FOR THIS KIND OF CONTAMINATION COULD BE IDENTIFIED IN THE MANUFACTURING LINE. A BATCH RECORD REVIEW FOR THE REPORTED LOT NUMBER DID NOT REVEAL ANY ABNORMALITIES OR NON-CONFORMANCES OF THIS NATURE. NO ADVERSE QUALITY TRENDS OF THIS NATURE WERE IDENTIFIED DURING THE COMPLAINT REVIEW PROCESS FOR THE REPORTED CATALOG NUMBER. ALTHOUGH THE ORIGINAL COMPLAINT WAS FILED AGAINST ITEM 2112529, AFTER THE FT-IR ANALYSIS WAS PERFORMED IT WAS DETERMINED THAT TRANSFER SET 2112550 COULD HAVE CONTRIBUTED TO THE EVENT. PLEASE NOTE, MANUFACTURER REPORT 2523676-2018-00113 HAS BEEN FILED FOR THE TRANSFER SET. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    AS REPORTED BY USER FACILITY: AFTER FILLING, DURING FINAL INSPECTION, WE FOUND A SMALL WHITE FLOATER IN THE BAG. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709560 APEX¿ CONTAINER, I.V. KPE B. BRAUN AVITUM ITALY S.P.A. 18E29 04046964539121

    Patients

    Seq Age Sex Outcome Treatment
    1