BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD Q-SYTE CLOSED LUER ACCESS DEVICE

    MDR report key: 20231879 · Received September 16, 2024

    Report

    Report Number
    1710034-2024-01025
    Event Type
    Malfunction
    Date Received
    September 16, 2024
    Date of Event
    August 9, 2024
    Report Date
    August 30, 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
    003

    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 THE DEFECT/CONDITION OF ADAPTER / CONNECTOR DEFECTIVE / DAMAGED WITH LOT 3122412 REGARDING ITEM #385100. LOT 3244493 IS A FINAL PRODUCT LOT. THE Q-SYTE SUBASSEMBLIES USED IN THAT FINAL LOT WAS BUILT UNDER PART NUMBER 8001498, LOT NUMBERS 3088214 AND 3088213. DHR FOR LOT 3088214 WAS REVIEWED. THE LOT WAS BUILT, AND BULK PACKAGED ON QFA LINE 2 FROM 15APR2023 THROUGH 17APR2023 FOR A TOTAL QUANTITY OF (B)(4) UNITS. NO RELATED QUALITY ISSUES OR DEVIATIONS WERE FOUND DURING THE MANUFACTURE OF THE SUBASSEMBLY BATCH. DHR FOR LOT 3212013 WAS REVIEWED. THE LOT WAS BUILT, AND BULK PACKAGED ON QFA LINE 2 FROM 06APR2023 THROUGH 09APR2023 FOR A TOTAL QUANTITY OF (B)(4) UNITS. NO RELATED QUALITY ISSUES OR DEVIATIONS WERE FOUND DURING THE MANUFACTURE OF THE SUBASSEMBLY BATCH. A REVIEW OF THE APPLICABLE AEURA RM4678 REV11(I) INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY IN THE RISK MANAGEMENT DOCUMENTATION. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. 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 CONNECTOR WAS DISLODGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: WHILE PERFORMING INFUSION LINE CARE TO REPLACE AN INFUSION CONNECTOR FOR A POSTOPERATIVE PATIENT, THE NURSE NOTICED THAT THE INFUSION CONNECTOR SEPTUM WAS DISLODGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2531182 BD Q-SYTE CLOSED LUER ACCESS DEVICE SET, ADMINISTRATION, INTRAVASCULAR FPA BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3122412 00382903851003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown