BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Q-SYTE

    MDR report key: 23213462 · Received October 3, 2025

    Report

    Report Number
    1710034-2025-01604
    Event Type
    Malfunction
    Date Received
    October 3, 2025
    Date of Event
    July 31, 2025
    Report Date
    October 14, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FPA
    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

    CUSTOMER RESPONSE RECEIVED ON 09-OCT-25. DID NOT AFFECT THE PATIENT'S TREATMENT, HAS BEEN GIVEN THE RELEVANT TREATMENT.

    Description of Event or Problem · 0

    ON (B)(6) 2025, THE PATIENT WAS ADMITTED FOR ABDOMINAL PAIN. ON (B)(6) INTRAVENOUS THERAPY WAS ADMINISTERED PER MEDICAL ORDERS. DURING TREATMENT USING A NEEDLE-FREE CLOSED-SYSTEM INFUSION CONNECTOR WITH A DIAPHRAGM, LEAKAGE FROM THE DIAPHRAGM WAS DETECTED, RENDERING IT UNUSABLE. THE DEVICE WAS IMMEDIATELY DISCONTINUED AND REPLACED WITH A NEW NEEDLE-FREE CLOSED-SYSTEM INFUSION CONNECTOR WITH A DIAPHRAGM. FOLLOWING REPLACEMENT, THE PATIENT COMPLETED TREATMENT WITHOUT INCIDENT. THIS ADVERSE EVENT RESULTED IN A DELAY IN THE PATIENT'S INTRAVENOUS THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1904232 Q-SYTE SET, ADMINISTRATION, INTRAVASCULAR FPA BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5031462

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown