BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD Q-SYTE CLOSED LUER ACCESS DEVICE

    MDR report key: 18117384 · Received November 12, 2023

    Report

    Report Number
    1710034-2023-01301
    Event Type
    Malfunction
    Date Received
    November 12, 2023
    Date of Event
    September 19, 2023
    Report Date
    December 14, 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

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE PHOTOGRAPH AND VIDEO SUBMITTED FOR EVALUATION. BD RECEIVED ONE PHOTOGRAPH WHICH DISPLAYED THE LABEL FROM THE TOP WEB LABEL REFERENCING MATERIAL NUMBER 385100, LOT NUMBER 2182891. THE INTERNATIONAL OVER-LABEL WAS SHOWN ON THE TOP WEB. THE VIDEO SHOWED THE Q-SYTE CONNECTOR ATTACHED TO TWO DIFFERENT COMPONENTS (ONE WITH THE MALE LUER AND ONE WITH THE FEMALE LUER). A DROP OF CLEAR LIQUID WAS OBSERVED BETWEEN THE FEMALE LUER OF THE Q-SYTE CONNECTOR AND A NON-BD EXTENSION SET. AS THE VIDEO SUPPORTS THE REPORTED EVENT, THE COMPLAINT 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. THE VIDEO PROVIDED FOR THIS INCIDENT DID NOT PRESENT SUFFICIENT EVIDENCE TO ESTABLISH A DEFINITE ROOT CAUSE. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD Q-SYTE CLOSED LUER ACCESS DEVICE LEAKED AT THE CONNECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: AT AROUND 9:30 AM ON (B)(6) 2023, IN THE SECOND DEPARTMENT OF RADIOTHERAPY, THE PATIENT SUFFERED FROM "MAINTENANCE CHEMOTHERAPY FOR MALIGNANT TUMORS, IMMUNOTHERAPY FOR MALIGNANT TUMORS, RECURRENCE OF GASTRIC MALIGNANT TUMORS, SECONDARY MALIGNANT TUMORS OF THE LIVER, SECONDARY MALIGNANT TUMORS OF THE PERITONEUM, AND SECONDARY MALIGNANT TUMORS OF THE PLEURA." "RECURRENT MALIGNANT TUMOR" WAS ADMITTED TO THE HOSPITAL, DURING WHICH MAINTENANCE CHEMOTHERAPY WITH THIS PRODUCT WAS REQUIRED. THE NURSE IN CHARGE TOOK OUT THE NEEDLELESS SEALED INFUSION CONNECTOR WITH A COMPLETE OUTER PACKAGING, DEFLATED THE INFUSION SET ACCORDING TO THE NORMAL OPERATING PROCEDURES, AND USED THE INFUSION CONNECTOR TO CONNECT THE PICC TUBE. SHE FOUND THAT THERE WAS LEAKAGE AT THE CONNECTION BETWEEN THE NEEDLELESS SEALED INFUSION CONNECTOR WITH THE SEPARATOR FILM AND THE PICC TUBE. IT WAS SUSPECTED THAT THERE WAS A PROBLEM WITH THE SEPARATOR MEMBRANE NEEDLELESS SEALED INFUSION CONNECTOR, SO I IMMEDIATELY REPLACED IT WITH ANOTHER SEPARATOR MEMBRANE NEEDLELESS SEALED INFUSION CONNECTOR OF THE SAME BRAND, SAME SPECIFICATION, MODEL, AND BATCH. THE ABOVE PHENOMENON DID NOT RECUR, SO IT WAS DETERMINED THAT THE SEPARATOR MEMBRANE WAS NEEDLELESS. THE SEALED INFUSION CONNECTOR IS FAULTY. THE ABOVE-MENTIONED ADVERSE EVENTS ARE SERIOUS ADVERSE EVENTS BECAUSE CHEMOTHERAPY DRUGS ARE CORROSIVE AND LEAKAGE INTO THE SKIN MAY CAUSE REDNESS, SWELLING, PAIN OR EVEN ULCERATION OF THE PATIENT'S SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192659 BD Q-SYTE CLOSED LUER ACCESS DEVICE INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 2182891 00382903851003

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown