BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD Q-SYTE CLOSED LUER ACCESS DEVICE

    MDR report key: 19192907 · Received April 26, 2024

    Report

    Report Number
    1710034-2024-00362
    Event Type
    Malfunction
    Date Received
    April 26, 2024
    Date of Event
    March 15, 2024
    Report Date
    May 7, 2024
    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

    INVESTIGATION RESULTS: NO PHOTOGRAPHIC EVIDENCE OR PHYSICAL SAMPLES WERE ACCESSIBLE TO INVESTIGATE THE REPORTED CONDITION. OUR QUALITY ENGINEER TEAM CONDUCTED A COMPREHENSIVE REVIEW OF THE DEVICE HISTORY RECORD FOR THE PROVIDED MATERIAL NUMBER 385100 AND LOT NUMBER 3093407. THIS REVIEW DID NOT UNCOVER ANY ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CAUSED THIS DEFECT, AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN THE SPECIFIED STANDARDS. UNFORTUNATELY, THE EXACT CAUSE OF THIS INCIDENT COULD NOT BE DETERMINED BASED ON THE INFORMATION AVAILABLE. WE WILL CONTINUE TO TRACK AND ANALYZE COMPLAINTS RELATED TO THIS DEVICE AND THE REPORTED CONDITION IN ORDER TO IDENTIFY ANY EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD Q-SYTE CLOSED LUER ACCESS DEVICE SEPTUM RUPTURED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: (B)(6) 2024 THE NURSE FOUND THAT THE CONNECTOR WAS LEAKING WHEN CHANGING THE LIQUID, AND FOUND THAT THE UPPER SOFT SILICONE WAS RUPTURED AFTER REMOVING THE LIQUID CONNECTOR

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2308295 BD Q-SYTE CLOSED LUER ACCESS DEVICE SET, ADMINISTRATION, INTRAVASCULAR FPA BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3093407 00382903851003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown