BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMODIALYSIS BLOODLINES

    MDR report key: 23358624 · Received October 22, 2025

    Report

    Report Number
    2521402-2025-01263
    Event Type
    Malfunction
    Date Received
    October 22, 2025
    Date of Event
    September 24, 2025
    Report Date
    November 18, 2025
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    FJK
    UDI-DI
    04046964367786
    PMA / PMN Number
    K080807
    Removal / Correction Number
    Z-0070-2026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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). EVENT 2 PHOTOS WERE PROVIDED DEPICTING THE PRODUCT AND THE REPORTED ISSUE TO THE MANUFACTURER. ALTHOUGH NO SAMPLES WERE PROVIDED, THE REPORTED EVENT IS SIMILAR TO A KNOWN ISSUE OF AIR IN LINE DURING USE. 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. THE REPORTED ISSUE IS DUE TO A MANUFACTURING ISSUE WITH THE ARTERIAL AND VENOUS PATIENT CONNECTORS, WHICH MAY ALLOW AIR LEAKAGE RESULTING IN MICROBUBBLES IN THE LINE, WHICH COULD THUS TRIGGER AIR-IN-LINE ALARMS. AN APPROVED PROJECT IS IN THE PLACE TO FURTHER ADDRESS ISSUES WITH AIR IN LINE. ADDITIONALLY, B. BRAUN MEDICAL INC. (BBMI) ISSUED A VOLUNTARY URGENT FIELD SAFETY CORRECTION FOR STREAMLINE® BLOODLINE SET FOR DIALOG+® HEMODIALYSIS SYSTEM (2521402-9/3/25-004-C [Z-0070-2026]). 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: EVENT 2 REASON OF COMPLAINT: OBSERVED 3 BLOOD LINES IN ONE LOT TO HAVE MICRO BUBBLES AT ARTERIAL ACCESS CONNECTION. USED DIFFERENT LOT NUMBER AND OBSERVED THE SAME. SECOND LOT NUMBER WAS A250021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229403 HEMODIALYSIS BLOODLINES SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE FJK B. BRAUN MEDICAL INC. A2500269 04046964367786

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown