BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD Q-SYTE CLOSED LUER ACCESS DEVICE

    MDR report key: 19281143 · Received May 9, 2024

    Report

    Report Number
    1710034-2024-00419
    Event Type
    Malfunction
    Date Received
    May 9, 2024
    Date of Event
    April 15, 2024
    Report Date
    July 1, 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
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). 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: THE COMPLAINT OF A LEAK WAS CONFIRMED; HOWEVER, THE ROOT CAUSE COULD NOT BE DETERMINED. THREE PHOTOGRAPHS AND ONE Q-SYTE CONNECTOR FROM LOT NUMBER #3093409 WERE PROVIDED FOR INVESTIGATION. A VISUAL OBSERVATION REVEALED NOTHING REMARKABLE; HOWEVER, A FUNCTIONAL TEST REVEALED A LEAK IN THE CONNECTOR DUE TO A TEAR IN THE COLUMN WALL OF THE SEPTUM. THIS TYPE OF DAMAGE MAY OCCUR DURING MANUFACTURING OR FROM MISALIGNMENT WITH THE MATING LUER TIP DURING USE. THE PRODUCT IFU STATES, "WHEN CONNECTING TO OR DISCONNECTING FROM THE BD Q-SYTE DEVICE ALWAYS INSERT OR REMOVE THE MALE LUER USING A 'STRAIGHT-ON/STRAIGHT-OFF' APPROACH. ANGLED INSERTIONS/REMOVALS MAY CAUSE POOR FUNCTIONING OR DAMAGE TO THE DEVICE." ALTHOUGH THE ROOT CAUSE COULD NOT BE DETERMINED, THE COMPLAINT HAS BEEN DOCUMENTED AND WILL CONTINUE TO BE MONITORED AS PART OF ONGOING EFFORTS TO IDENTIFY POTENTIAL MANUFACTURING RELATED ISSUES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD Q-SYTE CLOSED LUER ACCESS DEVICE LEAKED AT CONNECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: IT WAS REPORTED THAT LEAKAGE FROM PART OF THE CONNECTORS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520816 BD Q-SYTE CLOSED LUER ACCESS DEVICE SET, ADMINISTRATION, INTRAVASCULAR FPA BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3093409 00382903851003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown