BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Q-SYTE

    MDR report key: 23953868 · Received January 4, 2026

    Report

    Report Number
    1710034-2025-02014
    Event Type
    Malfunction
    Date Received
    January 4, 2026
    Date of Event
    December 2, 2025
    Report Date
    January 13, 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

    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 5120562. 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

    "POSITIVE PRESSURE CONNECTOR CRACKED AND LEAKED, PREVENTING COMPLETE DRUG DELIVERY INTO THE BLOODSTREAM, AFFECTING TREATMENT EFFECTIVENESS AND POTENTIALLY CAUSING BLOODSTREAM INFECTION." AND CLOSELY MONITOR THE PATIENT'S CONDITION". ON DECEMBER 2, A NEEDLELESS INJECTION CAP WITH A BARRIER SEPTUM WAS USED FOR THE PATIENT. ON DECEMBER 3, WHILE ADMINISTERING THE INFUSION, THE RESPONSIBLE NURSE DISCOVERED LEAKAGE AT THE INJECTION CAP SITE. THE PATIENT'S MEDICATION COULD NOT FULLY ENTER THE BLOODSTREAM, COMPROMISING TREATMENT EFFICACY AND POTENTIALLY CAUSING BLOODSTREAM INFECTION. THE INJECTION CAP WAS REPLACED ("AND CLOSELY MONITOR THE PATIENT'S CONDITION".).

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15462 Q-SYTE SET, ADMINISTRATION, INTRAVASCULAR FPA BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5120562 00382903851003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown