BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD Q-SYTE CLOSED LUER ACCESS DEVICE

    MDR report key: 20186294 · Received September 10, 2024

    Report

    Report Number
    1710034-2024-01009
    Event Type
    Malfunction
    Date Received
    September 10, 2024
    Date of Event
    August 15, 2024
    Report Date
    August 26, 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

    THE REPORTED DEFECT COULD NOT BE REFUTED NOR CONFIRMED IN THE ABSENCE OF A SAMPLE. THE ROOT CAUSE CANNOT BE DETERMINED FOR AN UNCONFIRMED DEFECT. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH FLOW ISSUES - FLUID BLOCKAGE LOT #3083105 REGARDING ITEM 385100. LOT 3083105 IS A FINAL PRODUCT LOT. Q-SYTE SUBASSEMBLIES USED IN THE FINAL LOT WERE BUILT UNDER PART NUMBER 8001498 LOT 3060966 AND 3060967. DHR FOR LOT 3060966 WAS REVIEWED. THE LOT WAS BUILT, AND BULK PACKAGED ON QFA LINE 2 FROM 02MAR2023 THROUGH 05MAR2023 FOR A TOTAL QUANTITY OF (B)(4) UNITS. NO DEVIATIONS WERE FOUND DURING THE MANUFACTURE OF THE SUBASSEMBLY BATCH. DHR FOR LOT 3060967 WAS REVIEWED. THE LOT WAS BUILT, AND BULK PACKAGED ON QFA LINE 2 FROM 07MAR2023 THROUGH 10MAR2023 FOR A TOTAL QUANTITY OF (B)(4) UNITS. NO RELATED QUALITY ISSUES OR DEVIATIONS WERE FOUND DURING THE MANUFACTURE OF THE SUBASSEMBLY BATCH. 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 SEPTUM FELL OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: AT 10:40 ON AUGUST 15, THE PATIENT'S INTRAVENOUS INFUSION WAS COMPLETED, THE NURSE USED THE SEPTUM NEEDLELESS CLOSED INFUSION CONNECTOR WITH THE PRE-FILLED CATHETER FLUSHER FOR THE PATIENT'S INDWELLING NEEDLE FLUSHING PROCESS FOUND THAT THE LIQUID IN THE FLUSHER COULD NOT FLOW, THE INSPECTION FOUND THAT THE SEPTUM OF THE SEPTUM NEEDLELESS CLOSED INFUSION CONNECTOR DIAPHRAGM FELL OFF AND BLOCKED THE CONNECTOR RESULTING IN THE INABILITY TO FLOW THE LIQUID, THE NURSE PACIFIED THE PATIENT'S EMOTIONS, AND REPLACED THE CONNECTOR USING OTHER SAME SPECIFICATIONS. THE NURSE CALMED THE PATIENT AND REPLACED IT WITH ANOTHER CONNECTOR OF THE SAME SPECIFICATION TO SUCCESSFULLY COMPLETE THE FLUSHING AND TUBE SEALING, AND THEN REPORTED TO THE NURSE MANAGER AND THE HOSPITAL PROCUREMENT DEPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2021237 BD Q-SYTE CLOSED LUER ACCESS DEVICE SET, ADMINISTRATION, INTRAVASCULAR FPA BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3083105 00382903851003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown