BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SMARTSITE¿ NEEDLE-FREE CONNECTOR

    MDR report key: 15794798 · Received November 14, 2022

    Report

    Report Number
    9616066-2022-01719
    Event Type
    Malfunction
    Date Received
    November 14, 2022
    Date of Event
    October 14, 2022
    Report Date
    November 7, 2022
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    10885403238345
    PMA / PMN Number
    K960280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER E-MAIL: UNKNOWN. 2000E CHINA 510K: THIS IS AN INTERNATIONAL CODE - THE MODEL#/CATALOG# IDENTIFIED 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 IS FOR THE DOMESTIC SIMILAR PRODUCT: K960280. INVESTIGATION SUMMARY: A 2000E CHINA PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION; HOWEVER, THE CUSTOMER INDICATED THE COMPLAINT SAMPLE WAS FROM LOT 22035662. THE FEEDBACK PROVIDED BY THE CUSTOMER INDICATES THAT A DISCONNECTION OCCURRED FROM THE SMARTSITE, RESULTING IN LEAKAGE. NO FURTHER INFORMATION WAS AVAILABLE TO ASSIST THE INVESTIGATION. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 22035662 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. 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. A REVIEW OF THE CUSTOMER FEEDBACK DATABASE INDICATES THAT THIS IS A RARE OCCURRENCE WITH A SMALL NUMBER OF SIMILAR REPORTS AGAINST THE 2000E CHINA PRODUCT IN THE PAST 12 MONTHS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SMARTSITE¿ NEEDLE-FREE CONNECTOR DISCONNECTED DURING THE FLUSH, CAUSING FLUID TO LEAK OUT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "THE PATIENT WAS HOSPITALIZED IN OUR HOSPITAL ON (B)(6) 2022. THE NEEDLE-FREE CLOSED INFUSION CONNECTOR WAS USED TO FLUSH THE TUBE. THE CONNECTOR REBOUNDED, CAUSING FLUID LEAKAGE. THE INFUSION CONNECTOR WAS REPLACED ON (B)(6) 2022, AND THE TUBE WAS SUCCESSFULLY FLUSHED ON (B)(6) 2022."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2774849 BD SMARTSITE¿ NEEDLE-FREE CONNECTOR INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 22035662 10885403238345

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown