BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMODIALYSIS BLOODLINES

    MDR report key: 24568207 · Received March 11, 2026

    Report

    Report Number
    24568207
    Event Type
    Malfunction
    Date Received
    March 11, 2026
    Date of Event
    January 8, 2026
    Report Date
    January 12, 2026
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    FJK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FDA ISSUED RECALL: (B)(4). IT WAS REPORTED TO US A PRESENCE OF A CRACK ON DIALYSIS ARTERIAL BLOOD LINE CONNECTOR NOTED AT THE START OF TREATMENT, NO AIR NOTED IN THE EXTRACORPOREAL CIRCUIT. BLOOD RETURNED THROUGH THE VENOUS LINE WITHOUT PROBLEM. DEFECTIVE DIALYSIS ARTERIAL BLOOD LINE PLACED INSIDE THE RED BAG AND WAS GIVEN TO LEAD TECHNICIAN, TO SUBMIT A PRODUCT COMPLAINT FOR INVESTIGATION. THE LOT LISTED BELOW WAS NOT MENTIONED IN THE FDA RECALL: MANUFACTURER: B BRAUN MEDICAL INC. MODEL: STREAMLINE AIRLESS SYSTEM SET: LOT: 62011828, EQUIPMENT INVENTORY NUMBER (EE/MX):REF: SL-2010M2096A, PROPOSE FDA ADD TO THE RECALL. MANUFACTURER RESPONSE FOR B BRAUN MEDICAL INC., B BRAUN MEDICAL INC. (PER SITE REPORTER). VENDOR OFFERED TO REPLACE DEFECTIVE PRODUCTS FROM THIS LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626883 HEMODIALYSIS BLOODLINES SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE FJK B. BRAUN MEDICAL INC. SL-2010M2096A 62011828

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other