BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASITE VALVE NEEDLELESS SYSTEM

    MDR report key: 3973253 · Received June 6, 2014

    Report

    Report Number
    9614279-2014-00029
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Report Date
    May 13, 2014
    Manufacturer
    B. BRAUN DOMINICAN REPUBLIC
    Product Code
    KGZ
    PMA / PMN Number
    K760385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TWO USED Y-EXTENSION SETS, AND ONE OPENED PACKAGE IDENTIFYING THE REPORTED LOT # 0061349795 WERE RECEIVED FOR EVALUATION. THE Y-EXTENSION SETS WERE SUBJECTED TO AIR PRESSURE AND WATER PRESSURE (LEAKAGE) TESTS ACCORDING TO SPECIFICATION WITH ACCEPTABLE RESULTS. THERE WERE NO LEAKAGES OBSERVED FROM ANY LOCATION ON THE SETS DURING THE TESTING TIME FRAME. REVIEW OF THE DISCREPANCY MGMT SYSTEM DATABASE PERFORMED FOR THE REPORTED LOT NUMBER DID NOT REVEAL ANY ABNORMALITIES OR NONCONFORMITIES OF THIS NATURE NOTED IN-PROCESS OR FINAL PRODUCT INSPECTION. NO ADVERSE QUALITY TRENDS OF THIS NATURE WERE IDENTIFIED DURING THE COMPLAINT REVIEW PROCESS FOR THE REPORTED CATALOG NUMBER OR LOT NUMBER. BASED ON THE RESULTS OF THIS INVESTIGATION, NO SPECIFIC CONCLUSIONS CAN BE MADE REGARDING THE CAUSE OF THE REPORTED EVENT. THE RETURNED SAMPLES MET REQUIREMENTS ACCORDING TO SPECIFICATION, AND THE REPORTED FAILURE COULD NOT BE REPRODUCED. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: EVENT #2: REPORTS THE SETS LEAKED CHEMO MEDICATION. THE CHEMO MEDICATION USED IS UNK. THE LOCATION OF THE LEAKS ON THE SETS IS ALSO UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331540 ULTRASITE VALVE NEEDLELESS SYSTEM SMALL BORE EXTENSION SETS WITH ULTRASITE KGZ B. BRAUN DOMINICAN REPUBLIC ET07US 0061349795

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK