BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS SMARTSITE NEEDLE-FREE VALVE

    MDR report key: 16916414 · Received May 11, 2023

    Report

    Report Number
    9616066-2023-00875
    Event Type
    Malfunction
    Date Received
    May 11, 2023
    Date of Event
    April 19, 2023
    Report Date
    May 12, 2023
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    10885403238345
    PMA / PMN Number
    K061285
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A 2000E CHINA PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION; AND THE LOT NUMBER WAS NOT PROVIDED IN THIS INSTANCE. THE FEEDBACK PROVIDED BY THE CUSTOMER SUGGESTS A COMPLETE OCCLUSION WAS DETECTED DURING USE OF THE SMARTSITE DEVICE. 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. THE LOT NUMBER WAS NOT AVAILABLE AND THEREFORE IT IS NOT POSSIBLE TO PERFORM A REVIEW OF THE PRODUCTION DOCUMENTATION FOR THIS PARTICULAR PRODUCT. THE ROOT CAUSE OF THE CUSTOMER¿S EXPERIENCE COULD NOT BE DETERMINED AS THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION. IN THIS INSTANCE, WITHOUT A SAMPLE, IT IS NOT POSSIBLE TO DETERMINE WHETHER A MANUFACTURING DEFECT COULD HAVE CAUSED OR CONTRIBUTED TO THE CUSTOMER¿S EXPERIENCE.

    Additional Manufacturer Narrative · 0

    2000E CHINA 510K: THIS IS AN INTERNATIONAL CODE - THE MODEL#/CATALOG# IDENTIFIED IN SECTION D4 IS A CAREFUSION PRODUCT WHICH IS SAME OR SIMILAR TO A DEVICE THAT IS APPROVED FOR SALE DOMESTICALLY. THE DOMESTIC SIMILAR LIST NUMBER IS 2000E. THE 510K NUMBER PROVIDED IN SECTION G5 IS FOR THE DOMESTIC SIMILAR PRODUCT: K061285. D.4 DEVICE EXPIRATION DATE: UNKNOWN. H.4 DEVICE MANUFACTURE DATE: UNKNOWN. H.6. INVESTIGATION SUMMARY: A 2000E CHINA PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION; AND THE LOT NUMBER WAS NOT PROVIDED IN THIS INSTANCE. THE FEEDBACK PROVIDED BY THE CUSTOMER SUGGESTS A COMPLETE OCCLUSION WAS DETECTED DURING USE OF THE SMARTSITE DEVICE. 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. THE LOT NUMBER WAS NOT AVAILABLE AND THEREFORE IT IS NOT POSSIBLE TO PERFORM A REVIEW OF THE PRODUCTION DOCUMENTATION FOR THIS PARTICULAR PRODUCT. THE ROOT CAUSE OF THE CUSTOMER¿S EXPERIENCE COULD NOT BE DETERMINED AS THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION. IN THIS INSTANCE, WITHOUT A SAMPLE, IT IS NOT POSSIBLE TO DETERMINE WHETHER A MANUFACTURING DEFECT COULD HAVE CAUSED OR CONTRIBUTED TO THE CUSTOMER¿S EXPERIENCE. PLEASE NOTE, PREVIOUS COMPLAINTS FOR OCCLUSIONS AND FLOW RESTRICTIONS 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 SMARTSITE COMPONENT IN THE PAST 12 MONTHS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE15 BD ALARIS SMARTSITE NEEDLE-FREE VALVE EXPERIENCED OCCLUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EMERGENCY DEPARTMENT NURSES OPEN THE PACKAGE AFTER PRE-FILLING FOUND THAT THE LIQUID DOES NOT GO

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE15 BD ALARIS SMARTSITE NEEDLE-FREE VALVE EXPERIENCED OCCLUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EMERGENCY DEPARTMENT NURSES OPEN THE PACKAGE AFTER PRE-FILLING FOUND THAT THE LIQUID DOES NOT GO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1310562 BD ALARIS SMARTSITE NEEDLE-FREE VALVE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. UNKNOWN 10885403238345

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown