BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESITE

    MDR report key: 3006900 · Received February 25, 2013

    Report

    Report Number
    2523676-2013-00033
    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
    N/A
    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). ONE (1) USED CARESITE VALVE WAS RECEIVED FOR EVALUATION WITH PACKAGING IDENTIFYING LOT NUMBER 0061254182. THE SAMPLE WAS SUBJECTED TO A LEAKAGE TEST WITH FAILING RESULTS. THE SAMPLE WAS THEN EXAMINED UNDER MAGNIFICATION, AND TWO CRACKS WERE NOTED IN THE CARESITE BODY. IN ADDITION, EIGHT (8) UNUSED CARESITE VALVES WERE RECEIVED FOR EVALUATION IN CLOSED PACKAGING IDENTIFYING LOT 0061254182. HOUSE RETAIN SAMPLES WERE ALSO OBTAINED FOR EVALUATION. ALL SAMPLES WERE SUBJECTED TO THE LEAKAGE TEST ACCORDING TO SPECIFICATION, WITH PASSING RESULTS. 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. THE INITIAL REPORT FROM THE 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 (B)(4) FOR 24 HOURS." ALTHOUGH THE REPORTED DEFECT WAS CONFIRMED, 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 VALVE CONNECTED TO PORT O CATH. TRIAL INFUSING 5FU AND LEAKED AFTER 3 DAYS OF USE. (B)(4), LOT NUMBER 0061254182.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79283 CARESITE CARESITE LUER ACCESS DEVICE FPA B. BRAUN MEDICAL, INC. NA 0061254182

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other