BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMODIALYSIS BLOODLINES

    MDR report key: 10983129 · Received December 10, 2020

    Report

    Report Number
    2521402-2020-00011
    Event Type
    Malfunction
    Date Received
    December 10, 2020
    Date of Event
    December 3, 2020
    Report Date
    March 9, 2021
    Manufacturer
    B. BRAUN MEDICAL INC
    Product Code
    FJK
    UDI-DI
    04046964367786
    PMA / PMN Number
    K080807
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4) EVENT 1. ONE (1) BLOOD TUBING SET WAS RECEIVED BY THE MANUFACTURER FOR EVALUATION. THE RETURNED SAMPLE WAS VISUALLY INSPECTED AND SMALL WHITE PARTICLES WERE OBSERVED IN THE VENOUS LINE FROM THE VENOUS CHAMBER TO THE END OF THE LINE, CONFIRMING THE REPORTED ISSUE. THE MANUFACTURER DETERMINED THE MOST LIKELY ROOT CAUSE OF THE PARTICLES WAS RESIN PRODUCED BY THE EXTRUSION MACHINERY. A REVIEW OF THE DEVICE HISTORY RECORDS FOR SL-2010M2096 LOT 00754032 WAS PERFORMED AND INDICATED THAT THERE WERE NO QUALITY ISSUES DURING THE MANUFACTURING PROCESS OF THIS LOT RELATED TO THE REPORTED ISSUE. A SEARCH OF THE COMPLAINT DATABASE FOR THIS BLOODLINE TUBING LOT NUMBER SHOWS NO ADDITIONAL REPORTS OF COMPONENT CONTAMINATION FOR THIS LOT NUMBER INDICATING THIS IS AN ISOLATED OCCURRENCE. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS EVENT 1 OF B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). THE DEVICE INVOLVED HAS NOT BEEN RECEIVED FOR EVALUATION AND THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

    Description of Event or Problem · 1

    EVENT 1: AS REPORTED BY USER FACILITY: AFTER RINSEBACK WAS COMPLETED, SEDIMENT WAS NOTED IN THE VENOUS LINE AND CHAMBER. NO PATIENT INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1447943 HEMODIALYSIS BLOODLINES BLOOD TUBING SETS FJK B. BRAUN MEDICAL INC SL-2010M2096 04046964367786

    Patients

    Seq Age Sex Outcome Treatment
    1