BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Q-SYTE

    MDR report key: 22994481 · Received September 8, 2025

    Report

    Report Number
    1710034-2025-01475
    Event Type
    Malfunction
    Date Received
    September 8, 2025
    Date of Event
    August 13, 2025
    Report Date
    September 9, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    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

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 385100 AND LOT NUMBER 5031462. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE, 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.

    Additional Manufacturer Narrative · 0

    H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Description of Event or Problem · 0

    ON (B)(6) 2025, DURING THE PROCESS OF ADMINISTERING AN INTRAVENOUS INFUSION TO A PATIENT, STAFF DISCOVERED THAT BOTH THE 10 ML AND 20 ML SYRINGES WERE LEAKING FLUID WHEN USING A NEEDLE-FREE CLOSED INFUSION CONNECTOR WITH A SEPARATOR MEMBRANE. THE 10 ML SYRINGE WAS PARTICULARLY SEVERE. AS A RESULT, A NEW NEEDLE-FREE CLOSED INFUSION CONNECTOR WITH A SEPARATOR MEMBRANE WAS REPLACED FOR THE PATIENT'S USE, AND NO HARM WAS CAUSED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2467241 Q-SYTE SET, ADMINISTRATION, INTRAVASCULAR FPA BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5031462 00382903851003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown