BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMODIALYSIS BLOODLINES

    MDR report key: 22726378 · Received August 6, 2025

    Report

    Report Number
    2521402-2025-00339
    Event Type
    Malfunction
    Date Received
    August 6, 2025
    Report Date
    November 12, 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
    CA, 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). THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW-UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    EVENT 7: ADDITIONAL INFORMATION: D9 DEVICE RETURNED TO MANUFACTURER DATE. THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). ONE (1) PICTURE AND THREE (3) SAMPLES RETURNED FOR EVALUATION. THROUGH VISUAL EXAMINATION, NO VISUAL DEFECTS WERE IDENTIFIED. THE SAMPLES WERE SUBJECTED TO A LEAK TEST PER SPECIFICATION WITH FAILING RESULTS. 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 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.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: EVENT 7. I AM A FACILITY ADMINISTRATOR WITH (B)(6). I AM REPORTING A PRODUCT ISSUE WITH BLOODLINES, STREAMLINE 8MM FOR BBRAUN SL-2010M2096. WE'VE HAD 8 INCIDENCES WHERE THERE WAS LEAKAGE AT THE VENOUS CONNECTOR WITH THE BLOODLINES, THE BLUE CONNECTOR IN THE ATTACHED IMAGE. THE TEAM TRIED TO RECONNECT IT TIGHTLY, BUT STILL HAVE LEAKAGE. ALL THE INCIDENCES INVOLVE BLOODLINES FROM LOT # A250024. WE HAVE PULLED THE BLOODLINES FROM SERVICE AND SO FAR HAVE NOT HAD ANY ISSUES WITH THE BLOODLINES FROM OTHER LOTS. -CUSTOMER CLARIFIED DURING A PHONE CALL ON 21JUL2025 THAT THERE WAS NO PATIENT INJURY JUST INSIGNIFICANT AMOUNT OF BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1725207 HEMODIALYSIS BLOODLINES SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE FJK B. BRAUN MEDICAL INC. A2500204 04046964367786

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown