BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS SMARTSITE NEEDLE-FREE VALVE

    MDR report key: 16681848 · Received April 5, 2023

    Report

    Report Number
    9616066-2023-00631
    Event Type
    Malfunction
    Date Received
    April 5, 2023
    Date of Event
    March 9, 2023
    Report Date
    March 17, 2023
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    20885403498227
    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

    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. H6: INVESTIGATION SUMMARY: A 2000E CHINA PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION; HOWEVER, THE CUSTOMER INDICATED THE COMPLAINT PRODUCT WAS FROM LOT 22046175. THE FEEDBACK PROVIDED BY THE CUSTOMER SUGGESTS LEAKAGE WAS DETECTED FROM THE SMARTSITE FEMALE LUER ADAPTOR IN CONNECTION WITH AN UNKNOWN PRODUCT. AS PART OF THE FEEDBACK THE CUSTOMER PROVIDED A PHOTOGRAPH; ANALYSIS OF THE PHOTOGRAPH CONFIRMED THE CUSTOMER'S EXPERIENCE AS A RED FLUID APPEARS TO BE LEAKING AT THE CONNECTION BETWEEN THE SMARTSITE AND AN UNKNOWN PRODUCT. HOWEVER, FROM THE PHOTOGRAPH IT IS NOT POSSIBLE TO IDENTIFY ANY OBVIOUS DAMAGE OR MANUFACTURING DEFECTS WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED LEAKAGE. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 22046175 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 WHILE USING BD ALARIS SMARTSITE NEEDLE-FREE VALVE LEAKAGE OCCURRED. THIS OCCURRED 3 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: ON MARCH 15TH, IT RECEIVED A COMPLAINT ABOUT THE QUALITY OF THE SMARTSITE 2000E NEEDLE-FREE AIRTIGHT INFUSION CONNECTOR FROM HOSPITAL. THE CONNECTOR LEAKED FROM THE CONNECTION END OF THE INFUSION SET, CAUSING BLOOD LEAKAGE AND BLOOD CONTAMINATION. THE NURSE IMMEDIATELY STOPPED THE INFUSION AND PULLED OUT THE AFTER FLUSHING THE TUBE, RECONNECT THE CONNECTOR FOR INFUSION. SINCE THE PRODUCT WAS CONTAMINATED WITH BLOOD, THE SAMPLE HAD BEEN DECONTAMINATED BY THE HOSPITAL AND COULD NOT BE RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2242314 BD ALARIS SMARTSITE NEEDLE-FREE VALVE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 22046175 20885403498227

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown