BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD Q-SYTE CLOSED LUER ACCESS DEVICE

    MDR report key: 20088698 · Received August 28, 2024

    Report

    Report Number
    1710034-2024-00951
    Event Type
    Malfunction
    Date Received
    August 28, 2024
    Date of Event
    July 27, 2024
    Report Date
    August 12, 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

    A COMPLAINT HISTORY CHECK WAS PERFORMED, AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF LEAKAGE WITH LOT # 3335366 AND MATERIAL # 385100. LOT 3335366 IS A FINAL PRODUCT LOT. THE Q-SYTE SUBASSEMBLIES USED IN THAT FINAL LOT WAS BUILT UNDER PART NUMBER 8001498, LOT NUMBERS 3296391 AND 3296396. DHR FOR LOT 3296391 WAS REVIEWED. NO RELATED QUALITY ISSUES OR DEVIATIONS WERE FOUND DURING THE MANUFACTURE OF THE SUBASSEMBLY BATCH. DHR FOR LOT 3296396 WAS REVIEWED. NO RELATED QUALITY ISSUES OR DEVIATIONS WERE FOUND DURING THE MANUFACTURE OF THE SUBASSEMBLY BATCH. ROOT CAUSE COULDN'T BE DETERMINED DUE TO NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION AVAILABLE FOR INVESTIGATION. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD Q-SYTE CLOSED LUER ACCESS DEVICE LEAKED AT T HE CONNECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: ON (B)(6)2024 AT 08:10 AN INFUSION WAS GIVEN TO A PATIENT, THE INFUSION WAS CLEAR, AT 08:30 THE PATIENT RANG THE BELL AND INFORMED THE NURSE THAT THE COLLAR WAS WET, THE NURSE CHECKED AND FOUND THAT THERE WAS A LEAK AT THE DIAPHRAGM CONNECTOR, THE DIAPHRAGM CONNECTOR WAS RE-REPLACED FOR THE PATIENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197860 BD Q-SYTE CLOSED LUER ACCESS DEVICE SET, ADMINISTRATION, INTRAVASCULAR FPA BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3335366 00382903851003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown