BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD Q-SYTE CLOSED LUER ACCESS DEVICE

    MDR report key: 21516041 · Received March 4, 2025

    Report

    Report Number
    1710034-2025-00352
    Event Type
    Malfunction
    Date Received
    March 4, 2025
    Date of Event
    February 9, 2025
    Report Date
    March 21, 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

    H3: A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: 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 4061304. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD Q-SYTE CLOSED LUER ACCESS DEVICE HAD A CRACK AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: ON FEBRUARY 9, DUE TO THE TREATMENT NEEDS FOR THE PATIENT INFUSION TREATMENT, INFUSION, THE PATIENT FOUND THAT THE CLOTHES ARE WET, THERE IS LIQUID OOZING, IMMEDIATELY RING THE BELL TO CALL THE NURSE, THE NURSE CHECKED AND FOUND THAT THERE IS A CRACK AT THE BD THREADS, RESULTING IN CONNECTING THE INFUSION DEVICE AND BD CONNECTOR LEAKAGE, IMMEDIATELY REPLACE THE NEW INFUSION CONNECTOR, FOR THE PATIENT TO RE-INFUSE THE LIQUID. LEAKAGE, WHICH LEADS TO IMPAIRED TREATMENT EFFECTIVENESS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1344928 BD Q-SYTE CLOSED LUER ACCESS DEVICE SET, ADMINISTRATION, INTRAVASCULAR FPA BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4061304 00382903851003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown