BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE

    MDR report key: 13869790 · Received March 23, 2022

    Report

    Report Number
    9610847-2022-00118
    Event Type
    Malfunction
    Date Received
    March 23, 2022
    Date of Event
    March 3, 2022
    Report Date
    March 10, 2022
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    30382903851004
    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 SUMMARY: OUR QUALITY ENGINEER INSPECTED THE PHOTOGRAPH AND VIDEO SUBMITTED FOR EVALUATION. BD RECEIVED ONE PHOTOGRAPH WHICH DISPLAYED THE TOP WEB (LABEL) OF A BD Q-SYTE, REFERENCE NUMBER 385100, LOT NUMBER 1082682. THERE IS ALSO A SECOND LABEL ADHERED TO THE TOP WEB. THE VIDEO SHOWS A SLIP LUER SYRINGE WITH CLEAR FLUID ATTACHED AT THE FEMALE LUER END OF THE Q-SYTE DEVICE. THE FLUID IS BEING FLUSHED THROUGH THE Q-SYTE WHILE THE BOTTOM OF THE Q-SYTE IS HELD CLOSED WITH A LABEL AND PRESSURE, AT WHICH TIME LEAKAGE IS OBSERVED FROM THE VENT HOLE. LEAKAGE FROM THE VENT HOLE IS NORMALLY ATTRIBUTED TO DAMAGED COLUMN WALL OF THE SEPTUM. DURING MANUFACTURING SEPTUM DAMAGE CAN BE CAUSED DUE TO DAMAGED OR DULL OR MISALIGNED BLADE DURING THE SEPTUM SLIT PROCESS. DURING USE, DAMAGE TO THE SEPTUM CAN OCCUR DUE TO EXCESSIVE ACTUATIONS AND EXTRANEOUS FORCE. 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. 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. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LIQUID LEAKED FROM THE BASE OF THE BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE. THIS OCCURRED 2 TIMES DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "LIQUID LEAKAGE AT THE BASE OF THE Q-SYTE SEPARATOR MEMBRANE NEEDLE-FREE CLOSED INFUSION CONNECTOR SEPARATOR MEMBRANE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715791 BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 385100 1082682 30382903851004

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown