BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Q-SYTE CLOSED LUER ACCESS DEVICE

    MDR report key: 19521246 · Received June 12, 2024

    Report

    Report Number
    1710034-2024-00575
    Event Type
    Malfunction
    Date Received
    June 12, 2024
    Date of Event
    May 11, 2024
    Report Date
    June 13, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    UDI-DI
    00382903851003
    PMA / PMN Number
    K013621
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 385100 AND LOT NUMBER 3083105. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. 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.

    Description of Event or Problem · 0

    ON MAY 11, 2024, WHEN CHANGING THE INFUSION PORT TO THE PATIENT, IT WAS FOUND THAT THE NEEDLE-LESS SEALED INFUSION CONNECTOR OF THE SEPARATOR MEMBRANE WAS RUPTURED, AND THE LIQUID LEAKED AND DRIPPED ONTO THE PATIENT'S SKIN.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368523 Q-SYTE CLOSED LUER ACCESS DEVICE SET, ADMINISTRATION, INTRAVASCULAR FPA BECTON DICKINSON 3083105 00382903851003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown