BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Q-SYTE

    MDR report key: 23952947 · Received January 3, 2026

    Report

    Report Number
    1710034-2025-02007
    Event Type
    Malfunction
    Date Received
    January 3, 2026
    Date of Event
    October 27, 2025
    Report Date
    January 12, 2026
    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 5031463. 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 THE MORNING OF (B)(6) 2025, WHILE NURSE WAS REPLACING THE IV EXTENSION TUBE FOR PATIENT (B)(6), SHE DISCOVERED THAT THE THREADED CONNECTION AT THE UPPER END OF THE EXTENSION TUBE WHERE IT JOINED THE NEEDLE-FREE CLOSED CONNECTOR HAD CRACKED. FLUID ADMINISTRATION VIA THE MICRO-PUSH PUMP PROCEEDED NORMALLY WITH NO LEAKAGE OR SEEPAGE. HOWEVER, THE EXTENSION TUBE COULD NOT BE UNSCREWED FROM THE NEEDLE-FREE CLOSED CONNECTOR. BOTH THE EXTENSION TUBE AND THE NEEDLE-FREE CLOSED CONNECTOR (USED FOR LESS THAN FIVE DAYS, BEFORE THE SCHEDULED REPLACEMENT TIME) HAD TO BE REPLACED. THIS INCIDENT CAUSED NO DIRECT HARM TO THE PATIENT BUT RESULTED IN THE PREMATURE REPLACEMENT OF THE EQUIPMENT, INCREASING THE PATIENT'S COSTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14507 Q-SYTE SET, ADMINISTRATION, INTRAVASCULAR FPA BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5031463 00382903851003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown