BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Q-SYTE

    MDR report key: 22520463 · Received July 16, 2025

    Report

    Report Number
    1710034-2025-01192
    Event Type
    Malfunction
    Date Received
    July 16, 2025
    Date of Event
    June 22, 2025
    Report Date
    July 18, 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

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

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 385100 AND LOT NUMBER 3213081. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD Q-SYTE LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT IS A CHRONIC LIVER FAILURE PATIENT WHO REQUIRES LONG-TERM INTRAVENOUS THERAPY VIA THE SUBCLAVIAN VEIN. TO ENSURE THE SAFETY OF THE INFUSION AND PREVENT BLOOD REFLUX, A SEPTUM-TYPE NEEDLELESS INJECTION CAP WAS CONNECTED TO THE RIGHT SUBCLAVIAN VEIN FOR INFUSION THERAPY AT 9:00 A.M. ON (B)(6) 2025, IN THE ICU. IT WAS FOUND THAT THE SEPTUM-TYPE NEEDLELESS INJECTION CAP COULD NOT PREVENT BLOOD REFLUX, SO IT WAS IMMEDIATELY REPLACED WITH A SEPTUM-TYPE NEEDLELESS INJECTION CAP, WHICH FUNCTIONED NORMALLY.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169655 Q-SYTE SET, ADMINISTRATION, INTRAVASCULAR FPA BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3213081 00382903851003

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male