BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SMARTSITE¿ NEEDLE-FREE VALVE

    MDR report key: 17916535 · Received October 11, 2023

    Report

    Report Number
    9616066-2023-02045
    Event Type
    Malfunction
    Date Received
    October 11, 2023
    Date of Event
    September 27, 2023
    Report Date
    November 28, 2023
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    37613203013629
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR (B)(4) FOLLOW UP MDR FOR DEVICE EVALUATION. NO SAMPLES WERE RETURNED FOR INVESTIGATION OF PR (B)(4), IN WHICH THE CUSTOMER HAS STATED: "THE CONNECTOR HAS RESISTANCE TO INFUSION AND SUSPENSION OF FLUID FLOW." THIS FEEDBACK RELATES TO A 2000E7D PRODUCT FROM LOT 1022314. FURTHER DETAILS RELATING TO THE NATURE OF THE REPORTED ISSUE, THE CLINICAL SET UP (INCLUDING DETAILS OF THE PRODUCT USED TO ACCESS THE 2000E7D), AND THE SEQUENCE OF EVENTS PRIOR TO THE ISSUE OCCURRING WERE NOT PROVIDED TO AID THE INVESTIGATION. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 1022314 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE CAUSED OR CONTRIBUTED TO A REPORT OF THIS NATURE. IN THIS INSTANCE, WITHOUT A SAMPLE TO EXAMINE IT HAS NOT BEEN POSSIBLE TO DETERMINE WHETHER A MANUFACTURING DEFECT COULD HAVE CAUSED OR CONTRIBUTED TO THE CUSTOMER'S EXPERIENCE; HOWEVER, PREVIOUS REPORTS OF THIS NATURE HAVE BEEN RELATED TO RAISED FEATURES ON THE SURFACE OF THE MALE LUER OF THE CONNECTING PRODUCT. THESE FEATURES, INCLUDING FLASH OR A RAISED EDGE TO THE TIP OF THE MALE LUER, HAVE PREVIOUSLY BEEN SHOWN TO LEAD TO INTERMITTENT RESTRICTED FLOW DUE TO PINCHING OF THE BLUE PISTON OF THE SMARTSITE WHICH SUBSEQUENTLY DOES NOT ALLOW IT TO OPEN FULLY. THIS CAN SOMETIMES BE RESOLVED BY DISCONNECTING AND REATTACHING THE SAME LUER CONNECTION WHICH MAY REPOSITION THE LUER AGAINST THE PISTON AND IMPROVE THE FLOW, OR ALTERNATIVELY BY CHANGING THE CONNECTING MALE LUER. IN THIS INSTANCE, WITHOUT THE COMPLAINT SAMPLE TO EXAMINE IT HAS NOT BEEN POSSIBLE TO CONCLUSIVELY LINK THIS FEEDBACK TO A SPECIFIC FAILURE MODE; HOWEVER, A REVIEW OF THE CUSTOMER ADVOCACY FEEDBACK DATABASE INDICATES THAT REPORTS OF THIS NATURE ARE RARE, WITH A SMALL NUMBER OF SIMILAR REPORTS RECEIVED AGAINST THE SMARTSITE COMPONENT IN THE LAST 12 MONTHS.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SMARTSITE¿ NEEDLE-FREE VALVE HAD FLOW ISSUES. THE FOLLOWING WAS TRANSLATED FROM PORTUGUESE TO ENGLISH: I WOULD LIKE TO INFORM YOU OF A PROBLEM WITH THE SMARTSITE CONNECTOR THE ASSOC PIAUIENSE COMB CANCER PRODUCT SENT TO THE CUSTOMER AS A SAMPLE TO VALIDATE THE TECHNOLOGY. ACCORDING TO THE CUSTOMER'S REPORT: THE CONNECTOR HAS RESISTANCE TO INFUSION AND SUSPENSION OF FLUID FLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1413854 BD SMARTSITE¿ NEEDLE-FREE VALVE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 1022314 37613203013629

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown