BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS SMARTSITE NEEDLE-FREE VALVE

    MDR report key: 17101741 · Received June 9, 2023

    Report

    Report Number
    9616066-2023-01148
    Event Type
    Malfunction
    Date Received
    June 9, 2023
    Date of Event
    May 19, 2023
    Report Date
    June 30, 2023
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    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

    INVESTIGATION SUMMARY: NO SAMPLES WERE RECEIVED FOR INVESTIGATION IN WHICH THE CUSTOMER HAS REPORTED TWO SEPARATE ISSUES: 1) BACKFLOW: "THE MATERIAL PRESENTS NEGATIVE PRESSURE (THE BLOOD RETURNS) DURING ITS USE" 2) FLOW RESTRICTION: "WE IDENTIFIED THE ATTACHED RESTRICTION" THIS FEEDBACK IS REGARDING 2000E7D PRODUCTS FROM LOT 1022314; HOWEVER NO FURTHER INFORMATION WAS AVAILABLE TO ASSIST THE INVESTIGATION IN THIS INSTANCE. PLEASE NOTE THAT THE 2000E7D PRODUCT IS NOT A BACK CHECK VALVE AND THEREFORE DURING USE IT MAY BE POSSIBLE FOR BACK FLOW TO OCCUR UNDER CERTAIN INFUSION RATES AND CLINICAL SET-UPS. WHEN THE SMARTSITE COMPONENT IS ACCESSED WITH A COMPATIBLE MALE LUER, IT IS EFFECTIVELY AN OPEN PATH, THROUGH WHICH FLUID CAN TRAVEL IN BOTH DIRECTIONS; HOWEVER, WHEN THE CONNECTING PRODUCT IS REMOVED, IT BECOMES A CLOSED SYSTEM. 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, A DEFINITIVE ROOT CAUSE OF THE CUSTOMER'S EXPERIENCE COULD NOT BE DETERMINED; 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. THE CONNECTING PRODUCT IN CLINICAL USE AT THE TIME OF THE CUSTOMER'S EXPERIENCE WAS NOT RECEIVED FOR INVESTIGATION; THEREFORE, IT WAS NOT POSSIBLE TO CONFIRM IF THE CONNECTING PRODUCT MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. E.1. INITIAL REPORTER PHONE #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 27 BD ALARIS SMARTSITE NEEDLE-FREE VALVE EXPERIENCED BLOOD BACKFLOW ISSUE DURING INFUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM- THE ASSISTANCE AREA HAS REGISTERED COMPLAINTS THAT THE MATERIAL PRESENTS NEGATIVE PRESSURE (THE BLOOD RETURNS) DURING ITS USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 27 BD ALARIS SMARTSITE NEEDLE-FREE VALVE EXPERIENCED BLOOD BACKFLOW ISSUE DURING INFUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM- THE ASSISTANCE AREA HAS REGISTERED COMPLAINTS THAT THE MATERIAL PRESENTS NEGATIVE PRESSURE (THE BLOOD RETURNS) DURING ITS USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2228625 BD ALARIS SMARTSITE NEEDLE-FREE VALVE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 1022314

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown