BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS SMARTSITE NEEDLE-FREE VALVE

    MDR report key: 19169961 · Received April 24, 2024

    Report

    Report Number
    9616066-2024-00614
    Event Type
    Malfunction
    Date Received
    April 24, 2024
    Date of Event
    March 1, 2024
    Report Date
    May 9, 2024
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    07613203011938
    PMA / PMN Number
    K223088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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

    INVESTIGATION RESULTS: NO SAMPLES WERE RECEIVED FOR INVESTIGATION OF PR 9941614, IN WHICH THE CUSTOMER HAS STATED: ¿THE CONNECTOR IS BLOCKED DURING USE¿. THE PRODUCT IN USE AT THE TIME IS REPORTED TO BE A 2000E CHINA FROM LOT 23035337. FURTHER CORRESPONDENCE FROM THE CUSTOMER CONFIRMED THAT SMARTSITE WAS CONNECTED WITH A SYRINGE WHEN THEY OBSERVED OCCLUSION. THE CUSTOMER ALSO CONFIRMED THAT THE REPORTED ISSUE WAS IDENTIFIED DURING PRIMING AND NORMAL SALINE WAS BEING INFUSED. MOREOVER, NO VISIBLE DEFECTS WERE OBSERVED ON THE REPORTED PRODUCT. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION, WHERE A REVIEW OF THE PRODUCTION RECORDS FOR LOT 23035337 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. HOWEVER, PREVIOUS COMPLAINTS FOR OCCLUSIONS HAVE BEEN RELATED TO FEATURES ON THE SURFACE OF THE MALE LUER OF THE CONNECTING PRODUCTS. THESE FEATURES INCLUDE FLASH OR A RAISED EDGE TO THE TIP OF THE MALE LUER WHICH HAVE PREVIOUSLY BEEN SHOWN TO INTERMITTENTLY LEAD TO RESTRICTED FLOW DUE TO THEM PINCHING THE BLUE PISTON OF THE SMARTSITE® AND NOT ALLOWING IT TO OPEN. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ALARIS SMARTSITE NEEDLE-FREE VALVE WAS OCCLUDED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT IS FOUND THAT THE CONNECTOR IS BLOCKED DURING USE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1189813 BD ALARIS SMARTSITE NEEDLE-FREE VALVE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A. DE C.V. 23035337 07613203011938

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown