BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESITE

    MDR report key: 3006931 · Received February 25, 2013

    Report

    Report Number
    2523676-2013-00032
    Event Type
    Malfunction
    Date Received
    February 25, 2013
    Date of Event
    December 14, 2012
    Report Date
    January 30, 2013
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    FPA
    PMA / PMN Number
    K083723
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL (B)(4). SINCE THE ACTUAL DEVICE INVOLVED IN THE REPORTED INCIDENT WAS NOT SAVED FOR EVALUATION, A THOROUGH EVALUATION COULD NOT BE PERFORMED. HOUSE RETAIN SAMPLES OBTAINED AND WERE SUBJECTED TO DIFFERENTIAL SCANNING CALORIMETRY (DSC) AND MELT FLOW RATE (MFR) TO COMPARE MAKROLONG POLYCARBONATE THERMAL PROFILES. HOUSE RETAIN SAMPLES SHOWED A TYPICAL PROFILE. A REVIEW OF THE NONCONFORMING LOT REPORT (NLR) DATABASE WAS PERFORMED FOR THE FINISHED GOOD, AND INVOLVED MOLDED COMPONENT LOTS, AND NO ABNORMALITIES OR NONCONFORMANCE'S WERE NOTED DURING IN-PROCESS OR AT FINAL PRODUCT INSPECTION. FOLLOW-UP CORRESPONDENCE WITH THE REPORTER FACILITY REVEALED THAT ONE VALVE LEAKED AFTER 3 DAYS. PER THE INSTRUCTIONS FOR USE (IFU) FOR THE CARESITE LUER ACCESS DEVICE (LAD), "THE LAD IS COMPATIBLE WITH LIPID EMULSION (CONTAINED IN TPN SOLUTION) AND CYTOTOXIC AGENTS CONTAINING CREMOPHOR (E.G. PACLITAXEL) FOR 24 HOURS." WITHOUT A SAMPLE, A COMPLETE INVESTIGATION COULD NOT BE CONDUCTED AND NO DEFINITIVE CONCLUSIONS CAN BE DRAWN. ALTHOUGH, BASED ON THE INFORMATION PROVIDED BY THE FACILITY, IT WOULD APPEAR THAT USING THE DEVICE BEYOND THE RECOMMENDED 24 HOURS LIKELY CONTRIBUTED TO THE REPORTED LEAKAGE. 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: OCCURRED (B)(6) 2012. REPORTS LEAKAGE AT THE JUNCTION OF THE VALVE AND SET, 5FU WAS BEING ADMINISTERED LEADING TO CHEMO LEAKAGE. NO SAMPLES AVAILABLE. (B)(4), LOT NUMBER 0061250151.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79334 CARESITE CARESITE LUER ACCESS DEVICE FPA B. BRAUN MEDICAL INC. NA 0061250151

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other