BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS SMARTSITE NEEDLE-FREE VALVE

    MDR report key: 18647154 · Received February 5, 2024

    Report

    Report Number
    9616066-2024-00185
    Event Type
    Malfunction
    Date Received
    February 5, 2024
    Date of Event
    February 2, 2023
    Report Date
    July 31, 2024
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    37613203013629
    PMA / PMN Number
    K960280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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 RECEIVED FOR INVESTIGATION OF (B)(4), IN WHICH THE CUSTOMER HAS STATED "OBSERVED THAT WHEN USING IT, THE MEDICATION IS NOT INFUSING EVEN WHEN THE ROUTE (CATHETER) IS PERVIOUS". THE PRODUCT IN USE AT THE TIME IS REPORTED TO BE A 2000E7D FROM LOT 1021435. NO FURTHER INFORMATION WAS AVAILABLE TO ASSIST THE INVESTIGATION IN THIS INSTANCE. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION, WHERE A REVIEW OF THE PRODUCTION RECORDS FOR LOT 1021435 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. A REVIEW OF THE CUSTOMER FEEDBACK DATABASE INDICATES THAT THIS IS A RARE OCCURRENCE WITH A SMALL NUMBER OF SIMILAR REPORTS AGAINST THE 2000E7D PRODUCT IN THE PAST 12 MONTHS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ALARIS SMARTSITE NEEDLE-FREE VALVE OCCLUDED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: THE MAX ZERO NEEDLELESS CONNECTOR IS BEING USED IN THE ICU TO SECURE THE SYSTEM OF VENOUS CATHETERS, BUT IT HAS BEEN OBSERVED THAT WHEN USING IT, THE MEDICATION IS NOT INFUSING EVEN WHEN THE ROUTE (CATHETER) IS PERVIOUS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2030429 BD ALARIS SMARTSITE NEEDLE-FREE VALVE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A. DE C.V. 1021435 37613203013629

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown