BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA PLUS3 BLUE

    MDR report key: 17987627 · Received October 23, 2023

    Report

    Report Number
    9610847-2023-00287
    Event Type
    Malfunction
    Date Received
    October 23, 2023
    Date of Event
    October 10, 2023
    Report Date
    November 9, 2023
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMG
    UDI-DI
    00382903946020
    PMA / PMN Number
    K974083
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OUR QUALITY ENGINEER INSPECTED THE 1 PHOTO SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF LEAKAGE WAS NOT CONFIRMED UPON INSPECTION OF THE PHOTO. THE REPORTED DEFECT COULD NOT BE OBSERVED IN THE PHOTO SUPPLIED. A PHYSICAL SAMPLE WOULD BE NEEDED TO FUNCTIONALLY TEST FOR THE REPORTED DEFECT. BD CANNOT CONFIRM THE CAUSE OF THE FAILURES TO OUR MANUFACTURING PROCESS SINCE NO SAMPLE WAS RETURNED FOR EVALUATION. WE WOULD BE VERY INTERESTED IN EXAMINING PRODUCT THAT DOES NOT MEET YOUR EXPECTATIONS AND OUR QUALITY STANDARDS. EXAMINATION OF THE ACTUAL PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE OF THE REPORTED FAILURE. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. 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. WE REGRET ANY INCONVENIENCES THIS INCIDENT MAY HAVE CAUSED YOU AND YOUR FACILITY.

    Additional Manufacturer Narrative · 0

    B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. 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 · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED OUR DISTRIBUTOR IN BULGARIA - RSR RECEIVED A COMPLAINT FROM THE NATIONAL HOSPITAL REGARDING THE LEAKAGE FROM BD CONNECTA¿ PLUS 3 360° BLUE (O4602-9), ART. NO. 394602, ACCORDING TO THE DELIVERED QUANTITIES BY US WITH THE FOLLOWING LOT NUMBERS: 3012416/ 31.01.2026; 3058487/ 31.01.2026; 3032920/ 31.01.2026 BASED ON THE SIGNED NEW TENDER CONTRACT WITH THE HOSPITAL. PLEASE BE AWARE THAT COMPLAINTS HAVE BEEN RECEIVED FROM SEVERAL DEPARTMENTS AFTER THE REPLACEMENT OF B. BRAUN¿S STOPCOCKS ACCORDING TO THE PREVIOUS TENDER CONTRACT.

    Description of Event or Problem · 0

    IT WAS REPORTED BD CONNECTA PLUS3 BLUE LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER; "OUR DISTRIBUTOR IN BULGARIA - RSR RECEIVED A COMPLAINT FROM THE NATIONAL HOSPITAL REGARDING THE LEAKAGE FROM BD CONNECTA¿ PLUS 3 360° BLUE (O4602-9), ART. NO. 394602, ACCORDING TO THE DELIVERED QUANTITIES BY US WITH THE FOLLOWING LOT NUMBERS: 3012416/ 31.01.2026; 3058487/ 31.01.2026; 3032920/ 31.01.2026 BASED ON THE SIGNED NEW TENDER CONTRACT WITH THE HOSPITAL. PLEASE BE AWARE THAT COMPLAINTS HAVE BEEN RECEIVED FROM SEVERAL DEPARTMENTS AFTER THE REPLACEMENT OF B. BRAUN¿S STOPCOCKS ACCORDING TO THE PREVIOUS TENDER CONTRACT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1950053 BD CONNECTA PLUS3 BLUE INTRAVASCULAR ADMINISTRATION SET FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 3032920 00382903946020

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown