BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX¿

    MDR report key: 24793126 · Received April 6, 2026

    Report

    Report Number
    9681240-2026-00008
    Event Type
    Malfunction
    Date Received
    April 6, 2026
    Report Date
    April 27, 2026
    Manufacturer
    B. BRAUN AVITUM ITALY S.P.A.
    Product Code
    KPE
    UDI-DI
    04046964539183
    PMA / PMN Number
    K041415
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). SIXTEEN POUCHES WITH A TOTAL OF EIGHTY (80) SAMPLES WERE SUBMITTED TO THE MANUFACTURER FOR EVALUATION. THROUGH VISUAL EXAMINATION, THE SHIPPING BOX DISPLAYED A PRODUCT CODE OF 2212529 AND BATCH NUMBER THAT DID NOT CORRESPOND TO THE PRODUCT CODE 2212530 AND BATCH NUMBER INDICATED ON THE POUCHES. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED FOR THE REPORTED LOT NUMBER, AND NO ABNORMALITIES OR NON-CONFORMANCES WERE NOTED DURING THE IN PROCESS OR FINAL PRODUCT INSPECTION. RESERVED SAMPLES WERE EXAMINED; NO DEVIATIONS WERE FOUND. BASED ON THE INVESTIGATION, THE REPORTED ISSUE OF MISLABELING WAS OBSERVED. THE MOST PROBABLY ROOT CAUSE IS ATTRIBUTED TO A TEMPORARY OVERSIGHT BY THE PRODUCTION DEPARTMENT DURING THE MANUFACTURING PHASE. IT WAS NOTED THAT NO CONCERNING TRENDS HAVE BEEN ASSESSED FOR THE TIME BEING. THE PRODUCTION DEPARTMENT HAS BEEN INFORMED TO START A COMPREHENSIVE INVESTIGATION AND TAKE APPROPRIATE ACTION. WE WILL MAINTAIN THIS REPORT FOR FURTHER REFERENCES AND CONTINUE TO MONITOR OTHER REPORTS FOR SIMILAR OCCURRENCES. IF ANY ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW-UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: THE OUTER BOX IS LABELED 500 ML BUT INSIDE THE OVERWRAP IS LABELED 1000ML AND ACTUALLY IS 500 ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24300 APEX¿ CONTAINER, I.V. KPE B. BRAUN AVITUM ITALY S.P.A. 25A21 04046964539183

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown