BEUDAMED
    FDA Adverse Event Other Summary report: N

    ULTRASITE

    MDR report key: 808162 · Received January 17, 2007

    Report

    Report Number
    2523676-2006-00114
    Event Type
    Other
    Date Received
    January 17, 2007
    Report Date
    January 8, 2006
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FPA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICES INVOLVED IN THE INCIDENTS WERE MADE AVAILABLE FOR THE MFR TO EVALUATE. A LOT NUMBER WAS NOT KNOWN. DIRECTIONS FOR USE ON THE ULTRASITE VALVE IFU STATES: USE ASEPTIC TECHNIQUE. SWAB INJECTION SITE PRIOR TO USE PER INSTITUTIONAL PROTOCOL. USE A LUER LOCK CONNECTOR WITHOUT A NEEDLE. FLUSH PER INSTITUTIONAL PROTOCOL USING SALINE ONLY OR SALINE WITH HEPARIN. REPLACE SET EVERY 24 HRS OR PER CDC GUIDELINES AND OR INSTITUTIONAL PROTOCOL. SEVERAL STUDIES HAVE BEEN CONDUCTED INDICATING NO INCREASE IN THE OCCURRENCE OF SEPSIS WITH THE USE OF ULTRASITE. ALL B. BRAUN STERILE PACKAGED LOTS ARE CERTIFIED AS STERILE PRIOR TO SHIPPING, AND THE APPROPRIATE RECORDS ARE KEPT ON FILE. SINCE A LOT NUMBER WAS NOT REPORTED LAL AND STERILITY TEST RESULTS COULD NOT BE REVIEWED FOR THIS INCIDENT. HOWEVER, ALL OUR STERILIZATION PROCESSES ARE VALIDATED AND MONITORED WITH BIOLOGICAL INDICATORS. IF PERTINENT INFO BECOMES AVAILABLE FROM THE FACILITY, A FOLLOW-UP REPORT WILL BE FILED. NO SPECIFIC CONCLUSIONS CAN BE DRAWN.

    Description of Event or Problem · 1

    AS REPORTED BY THE REG MGR PER THE FACILITY. INCREASED INFECTION- ALMOST 2 STANDARD DEVIATIONS ABOVE THE UNIT MEAN RATE PRIOR TO USE ON CENTRAL LINES- OCTOBER RESULTS ON ONE MED SURG UNIT. ADDITIONAL INFO PROVIDED BY THE FACILITY INDICATED A TRIAL OF THE PRODUCT WAS BEING PERFORMED AND THE FACILITY NOTED AN INCREASE IN INFECTION RATE WHEN TRIALING THE PRODUCT. NO ADDITIONAL INFO WAS AVAILABLE ON THE STATUS OF ANY OF THE PTS. THE LOT NUMBER REMAINS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRASITE ULTRASITE VALVE FPA B. BRAUN MEDICAL, INC. CSU100 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other