BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESITE (LAD)

    MDR report key: 3820658 · Received May 2, 2014

    Report

    Report Number
    2523676-2014-00149
    Event Type
    Malfunction
    Date Received
    May 2, 2014
    Report Date
    April 10, 2014
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FPA
    PMA / PMN Number
    K083723
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT # (B)(4). THREE USED CARESITE VALVES, WITHOUT PACKAGING, WERE RECEIVED FOR EVALUATION. TWO OF THE CARESITE VALVES WERE CONNECTED TO A SMALLBORE Y-EXTENSION SET (CATALOG #470021), AND THE THIRD VALVE WAS BY ITSELF IN A SEPARATE BAG. ON ALL THREE CARESITE VALVES, CRACKS AND SEVERAL STRESS MARKS/CRAZING LINES WERE OBSERVED ON THE FEMALE LUER LOCK THREADS OF THE MOLDED CARESITE VALVE BODY (CAVITY #'S 14B, 4B, AND 31, AND RESPECTIVELY). WITHOUT THE LOT NUMBER, A THOROUGH EVALUATION COULD NOT BE PERFORMED. ALTHOUGH THE DURATION OF USE FOR THE CARESITE VALVE COULD NOT BE CONFIRMED, IT IS INDICATED IN THE INSTRUCTIONS FOR USE (IFU) FOR THE REPORTED PRODUCT CATALOG NUMBER, "THE LUER ACCESS DEVICE IS COMPATIBLE WITH LIPID EMULSION (CONTAINING CREMOPHOR (E.G., PACLITAXEL) FOR TWENTY FOUR HOURS." 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 "SPRAYING OUT OF VALVE" AND LEAKING WHILE FLUIDS ARE RUNNING." CHEMO MEDICATION USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265519 CARESITE (LAD) CARESITE LUER ACCESS DEVICE FPA B. BRAUN MEDICAL, INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN NA.