BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONNECTA Q-SYTE WHT

    MDR report key: 23005752 · Received September 9, 2025

    Report

    Report Number
    9610847-2025-00302
    Event Type
    Injury
    Date Received
    September 9, 2025
    Date of Event
    August 10, 2025
    Report Date
    December 23, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    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: OUR QUALITY ENGINEER INSPECTED THE 2 PHOTOS SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF CONNECTION ISSUES WAS NOT CONFIRMED UPON INSPECTION OF THE SAMPLES. ANALYSIS OF THE PHOTOS SHOWED THAT NO DEFECT COULD BE OBSERVED. UNFORTUNATELY, THE PHYSICAL SAMPLE WAS LOST EITHER IN-TRANSIT TO THE TESTING FACILITY OR UPON RECEIPT AT THE TESTING FACILITY. NO FURTHER INVESTIGATION CAN BE PERFORMED AT THIS TIME. PLEASE UNDERSTAND THIS IS A RARE OCCURRENCE AND WE APOLOGIZE. IF THE SAMPLE BECOMES AVAILABLE, FURTHER TESTING WILL THEN BE PERFORMED. BD COULD NOT DETERMINE A MANUFACTURING RELATED ROOT CAUSE SINCE THE REPORTED DEFECT WAS NOT CONFIRMED DURING THE EVALUATION OF THE PHOTOS. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS 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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD CONNECTA Q-SYTE WHT-DISCONNECTION DESCRIPTION OF THE INCIDENT: THE KTC LINE DISCONNECTED FROM THE PATIENT AT THE CONEKPLUS CONNECTOR (REF: 201702) FROM ASEPINMED AND THE 3-WAY VALVE (REF 394501) FROM BD. CLINICAL CONSEQUENCES AND CURRENT CONDITION OF THE PATIENT OR PERSON INVOLVED: GAS EMBOLISM AND PATIENT PLACED IN A HYPERBARIC CHAMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2842685 CONNECTA Q-SYTE WHT INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention