BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS SMARTSITE NEEDLE-FREE VALVE

    MDR report key: 23088416 · Received September 18, 2025

    Report

    Report Number
    2243072-2025-01178
    Event Type
    Malfunction
    Date Received
    September 18, 2025
    Date of Event
    August 11, 2025
    Report Date
    November 21, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    K960280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULT: NO SAMPLES WERE RECEIVED FOR INVESTIGATION, IN WHICH THE CUSTOMER HAS STATED: "DESPITE BEING PURGED, WHEN A SYRINGE IS USED TO ADMINISTER THERAPY, AIR BUBBLES FORM WHICH CANNOT BE REMOVED FROM THE SYSTEM AND POSE A RISK TO CHILDREN. CLOTS ARE ALSO FORMING." THIS FEEDBACK RELATES TO 2000E7D PRODUCTS FROM LOT 1031499. NO FURTHER INFORMATION WAS AVAILABLE TO ASSIST THE INVESTIGATION IN THIS INSTANCE. AS TWO SEPARATE ISSUES WERE REPORTED, THE INVESTIGATION HAS BEEN CONDUCTED IN TWO PARTS. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION, WHERE A REVIEW OF THE PRODUCTION RECORDS FOR LOT 1031499 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE CAUSED OR CONTRIBUTED TO A REPORT OF THIS NATURE. THE ROOT CAUSE OF THE CUSTOMER¿S EXPERIENCE COULD NOT BE DETERMINED IN THIS INSTANCE, AS NO SAMPLES WERE RECEIVED FOR INVESTIGATION. WITHOUT A SAMPLE TO EXAMINE, IT IS NOT POSSIBLE TO DETERMINE WHETHER A MANUFACTURING DEFECT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLOT FORMATION. IN THIS INSTANCE, WITHOUT ANY COMPLAINT SAMPLES 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 THIS IS AN ISOLATED FEEDBACK WITH NO OTHER REPORTS OF THIS NATURE RECEIVED AGAINST THE 2000E7D PRODUCT IN THE LAST 12 MONTHS.

    Additional Manufacturer Narrative · 0

    E.1. INITIAL REPORTER FACILITY NAME: (B)(6). H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, 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 ALARIS SMARTSITE NEEDLE-FREE VALVE HAD AIR BUBBLES / AIR IN LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: IT FORMS AIR BUBBLES. DESPITE BEING PURGED, WHEN A SYRINGE IS USED TO ADMINISTER MEDICATION, AIR BUBBLES FORM THAT CANNOT BE REMOVED FROM THE SYSTEM AND POSE A RISK TO CHILDREN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2830481 BD ALARIS SMARTSITE NEEDLE-FREE VALVE INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON 1031499

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown