BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMODIALYSIS BLOODLINES

    MDR report key: 23210284 · Received October 3, 2025

    Report

    Report Number
    2521402-2025-01090
    Event Type
    Malfunction
    Date Received
    October 3, 2025
    Report Date
    April 17, 2026
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    FJK
    PMA / PMN Number
    K080807
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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). THIRTY-TWO (32) UNUSED SAMPLES, AND TWO (2) PHOTOGRAPHS WERE PROVIDED FOR EVALUATION. THE SUBMITTED PHOTOGRAPHS WERE REVIEWED AND CONFIRMED THE PRESENCE OF AIR BUBBLES WITHIN THE TUBING OF THE BLOODLINE. A TOTAL OF 32 SAMPLES WERE VISUALLY INSPECTED FOR OVERALL CONDITION. FIVE OF THESE SAMPLES EXHIBITED COSMETIC DEFECTS, INCLUDING FLASH, SIGNIFICANT FLASH, AND DIVOTS LOCATED AT THE ARTERIAL PC, THE VENOUS PC, OR AT BOTH CONNECTION POINTS. THE MINOR COSMETIC DEFECTS OBSERVED IN THE SAMPLES DO NOT AFFECT THE FUNCTIONALITY OF THE PRODUCT. THEREAFTER, LEAK TESTING WAS PERFORMED ON THE SAMPLES, AND NO LEAKAGE WAS DETECTED. BASED ON THE INVESTIGATION FINDINGS FROM THE PHOTOGRAPH PROVIDED THE REPORTED DEFECT OF AIR-IN-LINE WAS CONFIRMED. MULTIPLE COMPLAINTS RELATED TO AIR-IN-LINE CONCERNS WERE REPORTED ACROSS VARIOUS ITEMS, PROMPTING THE INITIATION OF SCARS TO INVESTIGATE THE ISSUE. THE SUPPLIER, GVS, CONDUCTED A THOROUGH REVIEW OF DEVICE HISTORY RECORDS AND FOUND NO EVIDENCE OF PRODUCTION ISSUES OR NON-CONFORMANCES. NO MANUFACTURING, MATERIAL, OR ENVIRONMENTAL ROOT CAUSES WERE IDENTIFIED. ENGINEERING EVALUATIONS, INCLUDING ACCELERATED AGING AND SIMULATED USE TESTING SAMPLES WITH FLASH AND DIVOTS AT THE LUER CONE, DEMONSTRATED NO AIR BUBBLE GENERATION, AND ALL SAMPLES MET APPLICABLE LEAK AND PERFORMANCE REQUIREMENTS. AS THE ISSUE COULD NOT BE REPRODUCED, A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED AT THIS TIME. HOWEVER, THIS CHANGE ADDRESSES AIR BUBBLE ADHESION OBSERVED IN TUBING FOLLOWING THE IMPLEMENTATION OF A DEHP-FREE RESIN. THE UPDATE IS LIMITED TO DESIGN DOCUMENTATION ONLY, WITH NO CHANGES TO THE BILL OF MATERIAL (BOM) OR PRODUCT TECHNICAL DRAWINGS AT THE DR SITE OR SUPPLIER LEVEL AT THIS TIME. EXISTING CONTROLS REMAIN IN PLACE IN ACCORDANCE WITH SOPMD2024904 AND QA116. ANY REQUIRED BOM AND DRAWING UPDATES WILL BE IMPLEMENTED THROUGH A FUTURE CHANGE CONTROL PROCESS. 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. 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: WE ARE NOTICING AIR BUBBLES IN THE LINES. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527452 HEMODIALYSIS BLOODLINES SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE FJK B. BRAUN MEDICAL INC. 0062021943

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown