BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX¿

    MDR report key: 9418773 · Received December 5, 2019

    Report

    Report Number
    9681240-2019-00082
    Event Type
    Malfunction
    Date Received
    December 5, 2019
    Report Date
    December 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
    NV, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). ONE (1) COMPOUNDED BAG WAS RECEIVED FOR EVALUATION. WHEN THE COMPOUNDED SOLUTION WAS FILTERED, A PARTICLE OF ABOUT 0.1 MM DIAMETER WAS FOUND IN THE BAG. 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 BAGS 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 NON-CONFORMANCES OF THIS NATURE. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE FILED. CORRECTED DATA: THE RESULTS AND CONCLUSION CODES WERE UPDATED TO REFLECT THE INVESTIGATION RESULTS.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). ONE (1) COMPOUNDED BAG WAS RECEIVED FOR EVALUATION. WHEN THE COMPOUNDED SOLUTION WAS FILTERED, A PARTICLE OF ABOUT 0.1 MM DIAMETER WAS FOUND IN THE BAG. 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 BAGS 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 NON-CONFORMANCE'S OF THIS NATURE. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    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 · 1

    AS REPORTED BY USER FACILITY: AFTER COMPOUNDING, DURING FINAL INSPECTION A WHITE, FLOATING PARTICULATE WAS OBSERVED SUSPENDED IN THE FINAL SOLUTION. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1211550 APEX¿ CONTAINER, I.V. KPE B. BRAUN AVITUM ITALY S.P.A. 2112531 19A22 04046964539206

    Patients

    Seq Age Sex Outcome Treatment
    1