BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS SMARTSITE NEEDLE-FREE VALVE

    MDR report key: 23765158 · Received December 10, 2025

    Report

    Report Number
    2243072-2025-01465
    Event Type
    Malfunction
    Date Received
    December 10, 2025
    Date of Event
    November 14, 2025
    Report Date
    December 15, 2025
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K960280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO SAMPLES WERE RECEIVED FOR INVESTIGATION OF PR (B)(4), IN WHICH THE CUSTOMER HAS STATED, "THIS ITEM IS NOT ALLOWING FLUIDS THROUGH". THE PRODUCT IN USE AT THE TIME IS REPORTED TO BE A 2000E7D FROM LOT 1031502. FURTHER INFORMATION FROM THE CUSTOMER HAS STATED THAT THE MEDICATION WAS NOT REFRIGERATED AND THERE WERE NO VISIBLE DEFECTS OBSERVED WITH THE PRODUCT. THE FLOW WAS COMPLETELY BLOCKED AND THERE WAS NO PATIENT IMPACT. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION, WHERE A REVIEW OF THE PRODUCTION RECORDS FOR LOT 1031502 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 SAMPLE WAS RECEIVED FOR INVESTIGATION. WITHOUT A SAMPLE TO EXAMINE IT IS NOT POSSIBLE TO DETERMINE WHETHER A MANUFACTURING DEFECT COULD HAVE CAUSED OR CONTRIBUTED TO A REPORT OF THIS NATURE. A REVIEW OF THE CUSTOMER FEEDBACK DATABASE INDICATES THAT THIS IS A RARE OCCURRENCE WITH A SMALL NUMBER OF SIMILAR REPORTS AGAINST THE PRODUCT 2000E7D 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 AN OCCLUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED THAT THIS ITEM IS NOT ALLOWING FLUIDS THROUGH. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: KINDLY CONFIRM THE LOT NO. 1031502 AS IT IS NOT FOUND FOR THE MATERIAL NO 2000E7D. THIS IS THE ONLY LOT NUMBER THEY HAVE AVAILABLE. PLEASE CONFIRM IF THE MEDICATION WAS STORED IN THE REFRIGERATOR? IF YES, WAS IT ALLOWED TO REACH ROOM TEMPERATURE BEFORE USE? = NO. PLEASE CONFIRM THE EXACT LOCATION OF OCCLUSION? = UNKNOWN. PLEASE CONFIRM IF THERE ARE ANY VISIBLE DEFECTS TO THE DEVICE I.E., CRACKS, FLASHES, KINKS? = NO. PLEASE CONFIRM WHETHER THE FLOW WAS COMPLETELY OR PARTIALLY BLOCKED? = FULLY. PLEASE CONFIRM IF THERE IS ANY PATIENT IMPACT OR HARM CAUSED TO THE PATIENT DUE TO THE INCIDENT? = NO IMPACT TO PATIENT. PLEASE CONFIRM THE NUMBER OF PRODUCTS AFFECTED. HOW MANY PRODUCTS ARE AFFECTED IN THIS LOT 1031502? ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148221 BD ALARIS SMARTSITE NEEDLE-FREE VALVE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A DE C.V. 1031502

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown