BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD Q-SYTE CLOSED LUER ACCESS DEVICE

    MDR report key: 22062816 · Received May 21, 2025

    Report

    Report Number
    1710034-2025-00874
    Event Type
    Malfunction
    Date Received
    May 21, 2025
    Date of Event
    March 22, 2025
    Report Date
    May 27, 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

    INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 385100 AND LOT NUMBER 4152203. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT 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 ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD Q-SYTE CLOSED LUER ACCESS DEVICE SEPTUM DAMAGE WITH LEAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE TEAM LEADER REPLACED THE PICC SEPTUM WITH A NEEDLELESS INJECTION CAP. WHEN FLUSHING THE TUBING WITH SALINE SOLUTION, FLUID LEAKED FROM THE WHITE CONNECTOR. AFTER ADJUSTING THE TECHNIQUE AND RECONNECTING THE TUBING TIGHTLY, LEAKAGE PERSISTED, AND THE WHITE RUBBER AT THE CONNECTOR DID NOT REBOUND. NO HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    938246 BD Q-SYTE CLOSED LUER ACCESS DEVICE SET, ADMINISTRATION, INTRAVASCULAR FPA BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4152203 00382903851003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown