BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SMARTSITE¿ NEEDLE-FREE CONNECTOR

    MDR report key: 17932835 · Received October 13, 2023

    Report

    Report Number
    9616066-2023-02085
    Event Type
    Malfunction
    Date Received
    October 13, 2023
    Date of Event
    May 16, 2023
    Report Date
    November 6, 2023
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO SAMPLES WERE RECEIVED FOR INVESTIGATION OF PR 8994269, IN WHICH THE CUSTOMER HAS STATED: ¿DURING THE INFUSION PROCESS OF THE PATIENT, THE INTRAVENOUS NEEDLE WAS LEFT IN PLACE AND THEN CONNECTED TO THE CONNECTOR. IT WAS FOUND THAT THE FLUID WAS BLOCKED AT THE CONNECTOR ¿. THE PRODUCT IN USE AT THE TIME IS REPORTED TO BE A 2000E CHINA FROM LOT 22046173. 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 22046173 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. 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. IN THIS INSTANCE, WITHOUT THE COMPLAINT SAMPLE TO EXAMINE IT HAS NOT BEEN POSSIBLE TO CONCLUSIVELY LINK THIS FEEDBACK TO A SPECIFIC FAILURE MODE; HOWEVER, 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.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION: DURING THE INFUSION PROCESS OF THE PATIENT, THE INTRAVENOUS NEEDLE WAS LEFT IN PLACE AND THEN CONNECTED TO THE CONNECTOR. IT WAS FOUND THAT THE FLUID WAS BLOCKED AT THE CONNECTOR AND NO DAMAGE WAS CAUSED TO THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SMARTSITE¿ NEEDLE-FREE CONNECTOR WAS OCCLUDED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "DURING THE INFUSION PROCESS OF THE PATIENT, THE INTRAVENOUS NEEDLE WAS LEFT IN PLACE AND THEN CONNECTED TO THE CONNECTOR. IT WAS FOUND THAT THE FLUID WAS BLOCKED AT THE CONNECTOR AND NO DAMAGE WAS CAUSED TO THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585788 BD SMARTSITE¿ NEEDLE-FREE CONNECTOR INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 22046173

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown