BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SMARTSITE¿ NEEDLE-FREE CONNECTOR, PRIMING VOLUME 0.11 ML

    MDR report key: 17936117 · Received October 13, 2023

    Report

    Report Number
    9616066-2023-02093
    Event Type
    Malfunction
    Date Received
    October 13, 2023
    Date of Event
    May 16, 2023
    Report Date
    November 7, 2023
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    10885403238345
    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 8994369, 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. 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 SMARTSITE COMPONENT IN THE PAST 12 MONTHS.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, 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 WHILE USING BD SMARTSITE¿ NEEDLE-FREE CONNECTOR, PRIMING VOLUME 0.11 ML THERE WAS A CLOG. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: 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
    682692 BD SMARTSITE¿ NEEDLE-FREE CONNECTOR, PRIMING VOLUME 0.11 ML INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 22046173 10885403238345

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown