BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA¿ STOPCOCK

    MDR report key: 9242223 · Received October 25, 2019

    Report

    Report Number
    9610847-2019-00642
    Event Type
    Malfunction
    Date Received
    October 25, 2019
    Date of Event
    October 3, 2019
    Report Date
    December 5, 2019
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMG
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING INFORMATION HAS BEEN UPDATED: B.5. DESCRIBE EVENT OR PROBLEM: IT HAS BEEN REPORTED THAT ONE BD CONNECTA¿ STOPCOCK HAS BEEN FOUND EXPERIENCING LEAKAGE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: FLUID LOSS OCCURS BY ADMINISTRATION VALVE. INFO ADD: THEY INFORMED THAT THE LEAKS OF THE BD CONNECTA EXTENDER BEGAN IMMEDIATELY AFTER THE INSTALLATION OF THE CATHETER WITHOUT ANY PRESSURE ON THE INFUSION. THE SAMPLES, HAVING BIOLOGICAL REMAINS, WERE ELIMINATED BY THE INSTITUTION. THEY WERE ONLY USED TO INFUSE PATIENTS WITH HYDRATION.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8180509. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING. WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT ONE BD CONNECTA¿ STOPCOCK HAS BEEN FOUND EXPERIENCING LEAKAGE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: FLUID LOSS OCCURS BY ADMINISTRATION VALVE. INFO ADD: THEY INFORMED THAT THE LEAKS OF THE BD CONNECTA EXTENDER BEGAN IMMEDIATELY AFTER THE INSTALLATION OF THE CATHETER WITHOUT ANY PRESSURE ON THE INFUSION. THE SAMPLES, HAVING BIOLOGICAL REMAINS, WERE ELIMINATED BY THE INSTITUTION. THEY WERE ONLY USED TO INFUSE PATIENTS WITH HYDRATION.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT ONE BD CONNECTA¿ STOPCOCK HAS BEEN FOUND EXPERIENCING LEAKAGE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: FLUID LOSS OCCURS BY ADMINISTRATION VALVE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT ONE BD CONNECTA¿ STOPCOCK HAS BEEN FOUND EXPERIENCING LEAKAGE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: FLUID LOSS OCCURS BY ADMINISTRATION VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1037289 BD CONNECTA¿ STOPCOCK STOPCOCK FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 8180509

    Patients

    Seq Age Sex Outcome Treatment
    1 Other