BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA¿ PLUS STOPCOCK

    MDR report key: 16009601 · Received December 19, 2022

    Report

    Report Number
    9610847-2022-00483
    Event Type
    Malfunction
    Date Received
    December 19, 2022
    Date of Event
    November 29, 2022
    Report Date
    July 10, 2024
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMG
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    1 SAMPLE (MODEL # 394910 ) WAS RECEIVED FOR INVESTIGATION. ADDITIONAL COMPONENTS OF THE SETUP WERE RECEIVED AND INVESTIGATED UNDER (B)(4). PRIOR TO FUNCTIONAL TESTING THE SAMPLE WAS VISUALLY EXAMINED FOR DEFECTS AND ABNORMALITIES. NO DEFECTS OR ABNORMALITIES WERE OBSERVED. THE SAMPLE WAS ATTACHED TO A BD EXTENSION SET (MODEL # MP5301-C). THE SETUP WAS FLUSHED BY USING 10 ML BD SYRINGE FILLED WITH 85% GLYCERIN / 15% WATER SOLUTION. THE SAMPLE FLUSHED SUCCESSFULLY WITH NO LEAKAGE OR FLUID BLOCKAGE WAS OBSERVED. THE CUSTOMER COMPLAINT THAT THERE WAS FLUID BLOCKAGE AND LEAKAGE WAS NOT REPLICATED. A DEVICE HISTORY RECORD REVIEW FOR MODEL 394910 AND LOT NUMBER 2062692 WAS PERFORMED. THE SEARCH SHOWED THAT LIST CONTAINS NO DATA. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET OF LOT. THE ROOT CAUSE OF THIS COMPLAINT COULD NOT BE DEFINITIVELY DETERMINED BECAUSE THE ISSUE COULD NOT BE REPLICATED. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. YOUR ASSISTANCE IN THIS MATTER HAS BEEN HELPFUL IN TREND IDENTIFICATION AND SUPPORTING OUR COMMITMENT TO CONTINUOUS QUALITY IMPROVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD CONNECTA¿ PLUS STOPCOCK WAS FOUND TO BE DRIPPING AND NO LIPIDS APPEARED TO BE MOVING FURTHER THAN THE BUFF CAP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UPON FURTHER INSPECTION THIS RN NOTICED THE BED WAS WET. THE SPECIFIC BUFF CAP THAT THE LIPIDS WERE HOOKED UP TO WAS FOUND TO BE WET AND DRIPPING AND NO LIPIDS APPEARED TO BE MOVING FURTHER THAN THAT BUFF CAP.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2084808 BD CONNECTA¿ PLUS STOPCOCK STOPCOCK FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 2062692

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown