BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS SMARTSITE NEEDLE-FREE VALVE

    MDR report key: 22896601 · Received August 26, 2025

    Report

    Report Number
    2243072-2025-01058
    Event Type
    Malfunction
    Date Received
    August 26, 2025
    Date of Event
    August 4, 2025
    Report Date
    September 25, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    K960280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE HUNDRED AND NINETY-FOUR 2000E7D SAMPLES WERE RECEIVED IN SEALED PACKAGING FOR INVESTIGATION OF (B)(4), IN WHICH THE CUSTOMER STATED: "THERE ARE ONGOING ISSUES WITH BLOOD AND FLUIDS LEAKING FROM THE PRODUCT ON HAND INJECTION PRIOR TO CT IMAGING." THE ORIGINAL FEEDBACK INDICATED THAT THE AFFECTED LOT WAS 1031715; HOWEVER, NO SAMPLES FROM THIS LOT WERE RECEIVED; INSTEAD, THE CUSTOMER PROVIDED ONE HUNDRED AND SIXTEEN SAMPLES FROM LOT 1031350, AND SEVENTY-EIGHT SAMPLES FROM LOT 1031499. FURTHER INFORMATION PROVIDED BY THE CUSTOMER HAS CLARIFIED THAT THE OBSERVED LEAKAGE OCCURRED "DURING HAND INJECTION OF SALINE PRIOR TO INJECTION OF CT CONTRAST," AND THAT THE SMARTSITE COMPONENT HAD NOT BEEN ACCESSED WITH A NEEDLE. ALL ONE HUNDRED AND NINETY-FOUR SAMPLES WERE SUBJECTED TO A VISUAL INSPECTION, DURING WHICH NO DAMAGE OR DEFECTS WERE OBSERVED. TEN SAMPLES FROM EACH LOT WERE THEN SELECTED, AT RANDOM, FOR ADDITIONAL FUNCTION TESTING WITH A BD PLASTIPAK SYRINGE, DURING WHICH THE SAMPLES WERE PRIMED AND THEN PRESSURE WAS APPLIED, BY HAND, FROM BOTH SIDES OF THE SMARTSITE COMPONENTS. NO LEAKAGE WAS OBSERVED DURING THE COURSE OF THIS TESTING. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. A REVIEW OF THE PRODUCTION RECORDS FOR LOT NUMBERS 1031715, 1031350, AND 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 CUSTOMER¿S EXPERIENCE WAS NOT CONFIRMED IN THIS INSTANCE. TESTING OF THE RETURNED SAMPLES AND A REVIEW OF THE PRODUCTION RECORDS DID NOT IDENTIFY ANY PRODUCT DEFECTS OR QUALITY DEVIATIONS DURING ASSEMBLY. THE ALLEGED COMPLAINT SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION THEREFORE IT WAS NOT POSSIBLE TO CONFIRM WHETHER A MANUFACTURING DEFECT MAY HAVE CONTRIBUTED TO THE REPORTED LEAKAGE. A REVIEW OF THE CUSTOMER ADVOCACY FEEDBACK DATABASE INDICATES THAT THIS IS A RARE OCCURRENCE, WITH A SMALL NUMBER OF SIMILAR REPORTS RECEIVED FOR LEAKAGE AGAINST THE SMARTSITE COMPONENT IN THE PAST 12 MONTHS.

    Additional Manufacturer Narrative · 0

    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 LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 2000E7D PORT SMARTSITE ALARIS BLOOD AND FLUIDS LEAKING ON HAND INJECTION PRIOR TO CT IMAGING WE HAVE BEEN NOTIFIED BY A COLLEAGUE IN OUR RADIOLOGY DEPARTMENT REGARDING AN ISSUE WITH PRODUCT CODE 2000E7D PORT SMARTSITE ALARIS AND THEY HAVE ADVISED THAT THERE ARE ONGOING ISSUES WITH BLOOD AND FLUIDS LEAKING FROM THE PRODUCT ON HAND INJECTION PRIOR TO CT IMAGING. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: WAS PATIENT OR USER HARMED? IF YES, PLEASE EXPLAIN. NO WAS ADDITIONAL MEDICAL INTERVENTION/MEDICATION REQUIRED? IF YES, PLEASE EXPLAIN. NO THE PROVIDED LOT NUMBER 1031715 DOES NOT APPEAR TO CORRESPOND WITH THE MATERIAL NUMBER 2000E7D. COULD YOU KINDLY VERIFY AND CONFIRM THE CORRECT LOT NUMBER FOR THE DEFECTIVE PRODUCT? - I HAVE THE FOLLOWING LOTS 1031715, 1031499, 1031350 PLEASE CONFIRM THE NUMBER OF PRODUCTS AFFECTED. 150 (100 FROM LOT 1031350 AND 50 FROM LOT1031499) PLEASE CONFIRM WHAT INTERNAL PRESSURE THE SMARTSITE HAD BEEN SUBJECTED TO (IF APPLICABLE) = HAND INJECTION PRESSURE PLEASE CONFIRM IF ANY PHYSICAL DAMAGE OR DEFORMITY WAS OBSERVED AT THE POINT OF LEAKAGE? = NO PLEASE CONFIRM IF THE SMARTSITE HAD BEEN ACCESSED WITH A NEEDLE? = NO PLEASE PROVIDE DETAILS OF THE STORAGE CONDITIONS PRIOR TO USE I.E., WHERE ARE THE PRODUCTS STORED? IS THE AREA TEMPERATURE CONTROLLED? = STORED IN CLINICAL STORES CUPBOARD AT AMBIENT ROOM TEMPERATURE WAS THE ISSUE IDENTIFIED WHILST IN USE ON A PATIENT OR DURING PRIMING AND SET UP? YES, DURING HAND INJECTION OF SALINE PRIOR TO INJECTION OF CT CONTRAST WAS THERE ANY EXTERNAL LEAKAGE IDENTIFIED? YES - LEAKING AT SMARTSITE WAS THE ISSUE IDENTIFIED WITH THE USER PRESENT AND ABLE TO INTERVENE AT THE TIME OF THE EVENT? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1406377 BD ALARIS SMARTSITE NEEDLE-FREE VALVE INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON 1031350

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown