BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS SMARTSITE NEEDLE-FREE VALVE

    MDR report key: 24508423 · Received March 4, 2026

    Report

    Report Number
    2243072-2026-00144
    Event Type
    Malfunction
    Date Received
    March 4, 2026
    Date of Event
    February 13, 2026
    Report Date
    March 12, 2026
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    K960280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    NO SAMPLES WERE RETURNED FOR INVESTIGATION OF (B)(4), IN WHICH THE CUSTOMER HAS STATED: "NFC IS DECREASING THE FLOW RATE." THIS FEEDBACK RELATES TO A 2000E7D PRODUCT, OF WHICH THE CUSTOMER HAS PROVIDED TWO LIKELY LOT NUMBERS, 1030574 AND 1030535. FURTHER CORRESPONDENCE WITH THE CUSTOMER CONFIRMED THAT THE FLUID IN USE IN BOTH VIDEOS WAS NORMAL SALINE AND ANTIBIOTICS; HOWEVER, THE CUSTOMER WAS UNABLE TO PROVIDE DETAILS OF THE PRODUCT TO WHICH THE 2000E7D WAS CONNECTED. ALTHOUGH NO SAMPLES WERE RECEIVED, THE CUSTOMER DID PROVIDE TWO SHORT VIDEOS, ANALYSIS OF WHICH CONFIRMED THE REPORT OF AN OCCLUSION AS ONE VIDEO SHOWS FLOW WITH NO SMARTSITE ATTACHED, WHILST THE SECOND VIDEO SHOWS NO FLOW WITH THE SMARTSITE ATTACHED. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION, WHERE A REVIEW OF THE PRODUCTION RECORDS FOR LOTS 1030574 AND 1030535 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 ANY SAMPLES 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; OF WHICH, THIS IS THE ONLY SUCH REPORT RECEIVED AGAINST PRODUCTS FROM EITHER OF THE REPORTED LOT NUMBERS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ALARIS SMARTSITE NEEDLE-FREE VALVE WAS OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT SLOWS DOWN THE FLOW RATE OF THE GRAVITY DRIVEN FLUID. NFC IS DECREASING THE FLOW RATE. DURING USE. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: WAS PATIENT OR USER HARMED? IF YES, PLEASE EXPLAIN. NO. AS YOU MENTIONED TWO LOTS, COULD YOU PLEASE CONFIRM WHETHER THE SAME PATIENT WAS INVOLVED OR DIFFERENT PATIENTS? IF YES, PLEASE PROVIDE THE RESPECTIVE DATE OF EVENT? YES, DIFFERENT PATIENTS, THE DATE IS THE SAME. COULD YOU PLEASE PROVIDE THE DATE OF EVENT FOR EACH LOT MENTIONED? 1030574: (B)(6) 2026, 1030535: (B)(6) 2026. PLEASE CONFIRM IF ANY PHYSICAL DAMAGE OR DEFORMITY WAS OBSERVED TO THE SMARTSITE COMPONENT OR THE MALE LUER OF THE CONNECTING PRODUCT? NO. PLEASE CONFIRM WHAT FLUID WAS BEING ADMINISTERED AT THE TIME OF THE EVENT? NORMAL SALINE, ANTIBIOTICS. PLEASE NOTE THAT IN INSTANCES OF FLOW RESTRICTION WITH SMARTSITE, THE TYPICAL CAUSE IS THE INTERACTION BETWEEN THE SMARTSITE COMPONENT, AND THE PRODUCT USED TO ACCESS IT. THEREFORE, PLEASE PROVIDE DETAILS OF THE PRODUCT USED TO ACCESS THE SMARTSITE, INCLUDING MANUFACTURER, MODEL AND LOT NUMBER. UNKNOWN. WAS THERE ANY EXTERNAL LEAKAGE? NO. WAS THE ISSUE IDENTIFIED PRIOR TO PATIENT USE AND CONNECTION OR DURING PATIENT USE? DURING PATIENT USE. WAS THE USER PRESENT AND ABLE TO MANIPULATE THE DEVICE AT THE TIME OF THE EVENT? NO.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571453 BD ALARIS SMARTSITE NEEDLE-FREE VALVE INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON 1030535

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown