BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTA Q-SYTE WHT

    MDR report key: 23290773 · Received October 15, 2025

    Report

    Report Number
    9610847-2025-00370
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    October 6, 2025
    Report Date
    October 24, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: AS NO PHYSICAL SAMPLE, PICTURE SAMPLE, OR LOT NUMBER WAS PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. THERE ARE CURRENT QUALITY CONTROLS IN PLACE TO DETECT THIS TYPE OF PRODUCT MALFUNCTION DURING THE PRODUCTION PROCESS. BASED ON THE LIMITED INVESTIGATION RESULTS, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    MEDICAL DEVICE VIGILANCE REPORT ON 3-WAY STOPCOCKS (REF: 394501): THE INFUSION LINE DISCONNECTED BETWEEN THE STOPCOCK AND THE EXTENSION TUBE FROM ASEPTIMED (REF: 202716). THIS HAPPENED TWICE ON THE SAME DAY, EVEN THOUGH THE LINES WERE SET UP BY DIFFERENT NURSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2021523 CONNECTA Q-SYTE WHT INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown