BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE NEEDLE-FREE VALVE

    MDR report key: 6041451 · Received October 19, 2016

    Report

    Report Number
    9616066-2016-01463
    Event Type
    Malfunction
    Date Received
    October 19, 2016
    Date of Event
    October 10, 2016
    Report Date
    October 11, 2016
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K061285
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, THE AFFECTED PRODUCT HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICES BE RECEIVED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: BD 10ML SYRINGE OF 0.9% NACL INJECTION, REF (B)(4), LOT 6182632, EXP 2019-06, THERAPY DATE: (B)(6) 2016. THE CUSTOMER¿S REPORT OF A LEAK IN THE TUBING WAS CONFIRMED. VISUAL INSPECTION WAS PERFORMED ON THE EXTENSION SET TO LOOK FOR DEFECTS SUCH AS CRACKS, KINKS, TEARS AND SEPARATIONS IN THE TUBING AND THE REST OF THE COMPONENTS. VISUAL INSPECTION DISCOVERED THAT THE FEMALE LUER OF THE MODEL 30914 EXTENSION HAD AN 11.4 MM CRACK. THERE WERE NO OTHER ANOMALIES OBSERVED. FUNCTIONAL TESTING CONFIRMED LEAKING AT THE FEMALE LUER CRACK. THE ROOT CAUSE OF THE LEAK WAS DETERMINED TO BE THE FEMALE LUER CRACK. THE ORIGIN OF THE CRACK IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK AT CONNECTION TO THE SMARTSITE DURING AN INFUSION ON A PATIENT. THERE IS NO REPORT OF PATIENT HARM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FLUID LEAKED FROM THE CONNECTION OF THE SYRINGE SET TO THE SMARTSITE DURING AN INFUSION OF FENTANYL AND SALINE FLUSHES. THE SET HAD BEEN IN USE FOR 6 HOURS. THERE IS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693404 SMARTSITE NEEDLE-FREE VALVE SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 30914

    Patients

    Seq Age Sex Outcome Treatment
    1