BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD Q-SYTE LUER ACCESS SPLIT SEPTUM

    MDR report key: 17156731 · Received June 19, 2023

    Report

    Report Number
    1710034-2023-00699
    Event Type
    Malfunction
    Date Received
    June 19, 2023
    Date of Event
    May 24, 2023
    Report Date
    July 6, 2023
    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

    H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THREE PHOTOGRAPHS SUBMITTED FOR EVALUATION. PHOTO 1 DISPLAYED THE PACKAGING LABEL WITH THE BD Q-SYTE UNDER ANOTHER LABEL. LOT NUMBER 2182891 AND EXPIRATION DATE OF 2027-05-31 ARE SHOWN. PHOTO 2 DISPLAYED A Q-SYTE UNIT AND EXTENSION TUBING ATTACHED TO THE PORT OF A YELLOW Y-ADAPTER. ON THE END OF THE Q-SYTE SEPTUM TOP DISK APPEARS TO BE A BEAD OF CLEAR FLUID. PHOTO 3 DISPLAYED THE TOP PORTION OF THE Q-SYTE DEVICE IS HELD BETWEEN A THUMB AND FINGER. WHAT COULD BE A CRACK WAS OBSERVED IN THE MIDDLE OF THE TOP BODY HOUSING. THE BEAD OF FLUID FROM PHOTO #2 WAS NOT LOCATED AT THIS FEATURE. THE REPORTED ISSUE WAS CONFIRMED. ALTHOUGH THE REPORTED ISSUE WAS CONFIRMED, IT COULD NOT BE DETERMINED IF THE DAMAGE RESULTED FROM THE MANUFACTURING OF THE DEVICE OR FROM THE USER ENVIRONMENT. DAMAGE TO THE SEPTUM BOTTOM DISK MAY OCCUR ON THE MANUFACTURING LINE DUE TO MISALIGNMENT OR DAMAGED PROBE. THE BEAD OF FLUID ON THE SEPTUM TOP DISK COULD BE A RESULT OF THE DAMAGE. THE BEAD OF FLUID ON THE SEPTUM TOP DISK COULD ALSO HAPPEN DURING APPLICATION AFTER THE DISCONNECTION FROM A FLUSH OR INFUSION DEVICE. THE PHOTO DOES NOT PROVIDE SUFFICIENT EVIDENCE TO DETERMINE IF THE TOP BODY WAS ACTUALLY CRACKED OR IF IT WAS REFLECTED LIGHT OR COSMETIC DAMAGE. COMPONENT DAMAGE COULD NOT BE CONFIRMED FROM THE PHOTOGRAPHS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 10 OF THE BD Q-SYTE LUER ACCESS SPLIT SEPTUM WAS CRACKED CAUSING LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: AFTER THE CUSTOMER UNWRAPPED THE OUTER PACKAGE OF THE Q-SAI JOINT, IT WAS FOUND THAT THERE WAS A CRACK ON THE OUTSIDE OF THE JOINT. AFTER CONNECTING THE Y-SHAPED INTERFACE SIDE OF THE INDWELLING NEEDLE AND STARTING INFUSION, IT WAS FOUND THAT THERE WAS WATER LEAKAGE AT THE JOINT, AND THE POSITIVE PRESSURE SEALING EFFECT COULD NOT BE ACHIEVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 10 OF THE BD Q-SYTE LUER ACCESS SPLIT SEPTUM WAS CRACKED CAUSING LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: AFTER THE CUSTOMER UNWRAPPED THE OUTER PACKAGE OF THE Q-SAI JOINT, IT WAS FOUND THAT THERE WAS A CRACK ON THE OUTSIDE OF THE JOINT. AFTER CONNECTING THE Y-SHAPED INTERFACE SIDE OF THE INDWELLING NEEDLE AND STARTING INFUSION, IT WAS FOUND THAT THERE WAS WATER LEAKAGE AT THE JOINT, AND THE POSITIVE PRESSURE SEALING EFFECT COULD NOT BE ACHIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2066049 BD Q-SYTE LUER ACCESS SPLIT SEPTUM INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 385100 2182891 00382903851003

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown