BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESITE (LAD)

    MDR report key: 3822986 · Received January 17, 2014

    Report

    Report Number
    2523676-2013-00441
    Event Type
    Malfunction
    Date Received
    January 17, 2014
    Report Date
    December 23, 2013
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FRN
    PMA / PMN Number
    K083723
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL DEVICE INVOLVED IN THE REPORTED INCIDENT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE ACTUAL SAMPLE, A THOROUGH EVALUATION COULD NOT BE PERFORMED AND NO SPECIFIC CONCLUSIONS CAN BE DRAWN. REVIEW OF THE DISCREPANCY MANAGEMENT SYSTEM DATABASE PERFORMED FOR THE REPORTED LOT NUMBER DID NO REVEAL ANY ABNORMALITIES OR NONCONFORMANCES OF THIS NATURE NOTED DURING IN-PROCESS OR FINAL PRODUCT INSPECTION. ALTHOUGH THE DURATION OF USE FOR THE CARESITE VALVE COULD NOT BE CONFIRMED, IT IS INDICATED ON THE INSTRUCTIONS FOR USE (IFU) FOR THE REPORTED PRODUCT CATALOG NUMBER. IF ADDITIONAL PERTINENT INFO BECOMES AVAILABLE, A FOLLOW-UP WILL BE FILED.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: EVENT # 1: REPORTS OF THREE VALVES LEAK AT THE BASE OF THE CENTRAL LINE. LEAKAGE OCCURRED EVEN WHEN THE VALVES WERE TIGHTENED VERY TIGHT. CHEMO WAS INFUSING WHEN THE LEAK. THIS ISSUE WAS ONLY FOUND WITH LOT # 0061328408.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45773 CARESITE (LAD) CARESITE LUER ACCESS DEVICE FRN B. BRAUN MEDICAL, INC. NA 0061328408

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other