BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESITE LUER ACCESS DEVICE

    MDR report key: 1944796 · Received December 10, 2010

    Report

    Report Number
    2523676-2010-00074
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    October 22, 2010
    Report Date
    November 17, 2010
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FPA
    PMA / PMN Number
    K083723
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED TO THE MFR TO BE EVALUATED. A CRACK, MEASURING APPROX 5 MM, WAS NOTED STARTING AT THE TOP OF THE FEMALE TAPER OF THE VALVE THROUGH THE LOCKING LUG AND THROUGH THE INTERFERENCE RIB OF THE TAPER. THE HOUSE RETAIN SAMPLES FOR THE REPORTED LOT AND TWENTY FIVE (25) SAMPLES FROM CURRENT INVENTORY OF THE REPORTED LOT WERE VISUALLY INSPECTED AND FUNCTIONALLY INSPECTED PER SPEC. THE SAMPLES WERE FLOW TESTED AND PRESSURE TESTED WITH NO LEAKS NOTED. THE SAMPLES PASSED ALL VISUAL AND PHYSICAL TESTING PER QUALITY SPEC. IN-PROCESS QUALITY TESTING DURING THE MFG PROCESS OF THIS PART VISUALLY INSPECTS FOR CRACKED COMPONENTS. PHYSICAL TESTING INCLUDES A HIGH PRESSURE BACK PRESSURE TEST, WATER CHALLENGE PRESSURE TEST AND A HIGH PRESSURE TEST, ALL FOR LEAKAGE. FINAL QUALITY INSPECTION INCLUDES A VISUAL INSPECTION FOR CRACKED COMPONENTS AND A HIGH PRESSURE TEST FOR LEAKAGE. A BATCH REVIEW WAS PERFORMED AND THERE WERE NO ABNORMALITIES OR NON-CONFORMANCES OF THIS NATURE NOTED AT IN-PROCESS OR FINAL INSPECTION FOR THE REPORTED LOT NUMBER. THERE IS INSUFFICIENT INFO PROVIDED WHICH WOULD SUGGEST THAT THE CRACKING IS ATTRIBUTABLE TO ANY QUALITY DEFICIENCY OR MFG DEFECT. IT SHOULD BE NOTED THAT THE REPORTED CRACK IS CONSISTENT WITH PREVIOUS INCIDENTS OF THIS NATURE INVOLVING CHEMOTHERAPY TREATMENTS IN WHICH THE COMBINATION OF SOLUTIONS USED, LENGTH OF EXPOSURE, AND/OR USER TECHNIQUE MAY CONTRIBUTE TO THE CRACKING OF THE PART. AS REPORTED BY THE USER FACILITY, THE PT WAS RECEIVING 5FU THROUGH A CONTINUOUS INFUSION PUMP USING A PICC LINE AND THE VALVE WAS ATTACHED TO THE PICC LINE FOR 4 DAYS WITHOUT BEING CHANGED. THE INSTRUCTIONS FOR USE WITH THE PRODUCT INDICATE THE DEVICE IS COMPATIBLE WITH LIPID EMULSION (CONTAINED IN TPN SOLUTIONS) AND CYTOTOXIC AGENTS CONTAINING CREMOPHOR (E.G., PACLITAXEL) FOR 24 HOURS. IT IS POSSIBLE THE CRACK IN THE VALVE OCCURRED DUE TO EXCESSIVE EXPOSURE TO THE CHEMOTHERAPY DRUG 5FU OVER THE 24 HOUR TIME PERIOD AS STATED IN THE INSTRUCTIONS FOR USE. A DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT WITH NO NON-CONFORMANCES NOTED. THERE ARE NO OTHER CONFIRMED REPORTS OF THIS NATURE AGAINST THE REPORTED PRODUCT CODE AND REPORTED LOT NUMBER. WE CONTINUOUSLY MONITOR PRODUCT INCIDENT REPORTS TO IDENTIFY TRENDS WHICH MIGHT AFFECT OUR PRODUCTS. NO ADVERSE TRENDS HAVE BEEN IDENTIFIED WITH THE REPORTED PRODUCT.

    Description of Event or Problem · 1

    AS REPORTED BY THE SALES REP PER THE USER FACILITY: CARESITE VALVE LEAKED CHEMO ONTO PT. LEAK APPEARED TO BE FROM THE MIDDLE ASPECT OF THE VALVE. ADD'L INFO PROVIDED BY THE FACILITY INDICATED THE PT WAS RECEIVING 5FU THROUGH A CONTINUOUS PUMP INFUSION AT HOME. WHEN THE PT WOKE IN THE MORNING, THEY NOTICED A LEAK. ALL CONNECTIONS WERE TIGHT AND THE LEAK APPEARED TO BE COMING FROM THE MIDDLE OF THE VALVE. IT WAS REPORTED THAT THE CONNECTIONS ARE SWABBED WITH ALCOHOL SWABS AND THE VALVE ITSELF IS NOT SWABBED. THE PT WAS ON A CONTINUOUS INFUSION PUMP USING A PICC LINE. THE INFUSION WAS STARTED ON (B)(6) 2010, AND THE VALVE WAS NOT CHANGED UNTIL (B)(6) 2010, WHEN THE INCIDENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARESITE LUER ACCESS DEVICE CARESITE VALVE FPA B. BRAUN MEDICAL, INC. NA 61090291

    Patients

    Seq Age Sex Outcome Treatment
    1 Other