BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD Q-SYTE CLOSED LUER ACCESS DEVICE

    MDR report key: 18510940 · Received January 15, 2024

    Report

    Report Number
    1710034-2023-01535
    Event Type
    Malfunction
    Date Received
    January 15, 2024
    Date of Event
    December 21, 2023
    Report Date
    February 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

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: RECEIVED ONE UNSEALED Q-SYTE CLOSED LUER ACCESS DEVICE. VISUAL INSPECTION DISCOVERED THAT THE SEPTUM WAS CAVED IN. THERE ALSO APPEARS TO BE DAMAGE TO THE TOP BODY. THE DAMAGE PRECLUDED PROPER ATTACHMENT OF A SYRINGE. THERE DOES NOT APPEAR TO BE ANY INDICATION OF USAGE. THE REPORTED DEFECT WAS CONFIRMED. THIS DEFECT MAY OCCUR DURING MANUFACTURING. DURING TOP BODY LOADING, THE TOP BODY IS ORIENTED AND TRANSFERRED FROM TOP BODY FEEDER BOWL TO THE INLINE TRACK. IMPROPER SETUP/ALIGNMENT OF FEEDER TRACK OR DAMAGED TRACK MAY CAUSE TOP BODY MISORIENTATION CAUSING SEPTUM DAMAGE/CAVE IN. BECAUSE OF THE EXTENT OF THE DAMAGE, THIS DEFECT MOST LIKELY OCCURRED DURING MANUFACTURING. INVESTIGATION CONCLUSION(S): THE DEFECT OF ¿FLOW ISSUES ¿ COMPLETE OCCLUSION¿ WAS CONFIRMED. PROBABLE ROOT CAUSE(S): MANUFACTURING. LOT 2118470 IS A FINAL PRODUCT LOT. Q-SYTE SUBASSEMBLIES USED IN THAT FINAL LOT WERE BUILT UNDER PART NUMBER 8001498 LOTS 2117610 AND 2123180. DHR FOR LOT 2117610 WAS REVIEWED. NO RELATED QUALITY ISSUES OR DEVIATIONS WERE FOUND DURING THE MANUFACTURE OF THE SUBASSEMBLY BATCH. DHR FOR LOT 2123180 WAS REVIEWED. NO RELATED QUALITY ISSUES OR DEVIATIONS WERE FOUND DURING THE MANUFACTURE OF THE SUBASSEMBLY BATCH. A NOTIFICATION OF AWARENESS HAS BEEN SENT TO THE MANUFACTURING DEPARTMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD Q-SYTE CLOSED LUER ACCESS DEVICE IS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: WHEN IN USE, CONNECTORS DON'T WORK ALTERNATE TRANSLATION USING GOOGLE TRANSLATE: SHORT DESCRIPTION: Q-SYTE-CLOGGED. LONG DESCRIPTION: WHEN IN USE, IF THE CONNECTOR IS BLOCKED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    954005 BD Q-SYTE CLOSED LUER ACCESS DEVICE INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 2118470 00382903851003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown