BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD Q-SYTE CLOSED LUER ACCESS DEVICE

    MDR report key: 21925001 · Received April 29, 2025

    Report

    Report Number
    1710034-2025-00696
    Event Type
    Malfunction
    Date Received
    April 29, 2025
    Date of Event
    March 1, 2025
    Report Date
    April 15, 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

    NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 385100 AND LOT NUMBER 4100572. 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. BASED ON THE AVAILABLE INFORMATION, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD Q-SYTE CLOSED LUER ACCESS DEVICE LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2025, THE NURSE GAVE THE PATIENT AN INDWELLING PICC LINE FOR SEALING AT THE END OF THE INFUSION AND FOUND THAT THERE WAS A LEAK AT THE HEPARIN CAP, REPLACED THE HEPARIN CAP, AND COMPLETED SEALING THE LINE, AND THIS ADVERSE EVENT DID NOT CAUSE ANY OTHER ADVERSE EFFECTS TO THE PATIENT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481035 BD Q-SYTE CLOSED LUER ACCESS DEVICE SET, ADMINISTRATION, INTRAVASCULAR FPA BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4100572 00382903851003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown