BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISCOFIX STOPCOCKS

    MDR report key: 3210090 · Received June 27, 2013

    Report

    Report Number
    2523676-2013-00193
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    June 4, 2013
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FMG
    PMA / PMN Number
    K760383
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL DEVICE INVOLVED IN THE REPORTED INCIDENT WAS NOT RETURNED FOR EVAL. WITHOUT THE ACTUAL SAMPLE OR LOT NUMBER, A THOROUGH EVAL COULD NOT BE PERFORMED AND NO SPECIFIC CONCLUSIONS CAN BE DRAWN. NO ADVERSE QUALITY TRENDS OF THIS NATURE WERE IDENTIFIED DURING THE COMPLAINT REVIEW PROCESS FOR THE PRODUCT CATALOG NUMBER IDENTIFIED IN THE REPORTED EVENT. ALL AVAILABLE INFO HAS BEEN FORWARDED TO THE DEVICE MFR OF THE NEEDLE. IF ADD'L PERTINENT INFO BECOMES AVAILABLE, A F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: REPORTS THE DEVICE IS LEAKING DURING CHEMO-EMBOLIZATION PROCEDURE, AND THE DEVICE APPEARS TO BE DISSOLVING. REPORTER IS UNSURE OF DRUG BEING USED, OR HOW PROCEDURE IS DONE. STATES THAT THE DEVICE IS NOT BEING USED WITH A PRESSURE INFUSER. STATES HE WILL TRY TO OBTAIN MORE CLINICAL INFO AND CALL BACK. UNK NUMBER OF EVENTS. NO SAMPLES AS THIS TIME. ON (B)(6) 2013, A RETURN CALL FROM THE REPORTER INDICATED HE DOES NOT KNOW WHAT DRUG IS BEING USED, BUT HAS HEARD THE SAME ISSUE IS HAPPENING AT (B)(6). ON (B)(6) 2013, AN EMAIL RECEIVED FROM THE REPORTER INDICATED THE TYPE OF CHEMO MEDICATION USED WITH THE THREE-WAY STOPCOCK IS: ETHIODOL, DOXORUBICIN, LIPIODOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292343 DISCOFIX STOPCOCKS D300 DISCOFIX 3-WAY STOPCOCK FMG B. BRAUN MEDICAL, INC. D300 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other