BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA PLUS3 10CM WHITE

    MDR report key: 19359931 · Received May 21, 2024

    Report

    Report Number
    9610847-2024-00134
    Event Type
    Malfunction
    Date Received
    May 21, 2024
    Date of Event
    March 4, 2024
    Report Date
    June 19, 2024
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMG
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OUR QUALITY ENGINEER INSPECTED THE 10 SAMPLES SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF CONNECTION ISSUES WAS NOT CONFIRMED UPON INSPECTION AND TESTING OF THE SAMPLES. ANALYSIS OF THE SAMPLES SHOWED THAT THERE WERE NO DEFECTS OR ABNORMALITIES. THE SAMPLES WERE FUNCTIONALLY TESTED, AND OUR TEST RESULTS SHOWED NO SIGNS OF THE FAILURE MODE. BD COULD NOT DETERMINE A MANUFACTURING RELATED ROOT CAUSE SINCE THE REPORTED DEFECT WAS NOT CONFIRMED DURING THE EVALUATION OF THE SAMPLE. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY. PRODUCTION RECORDS WERE REVIEWED, AND THIS BATCH MEETS OUR MANUFACTURING SPECIFICATION REQUIREMENTS. 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

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD CONNECTA PLUS3 10CM WHITE HAD CONNECTION ISSUES INCIDENT INFORMATION DATE OF OCCURRENCE: (B)(6) 2024 LOCATION (CHU SITES) : DM KEPT : I-YES DATE DM SENT : DM DISPATCHED TO : CIRCUMSTANCES/ DESCRIPTION OF INCIDENT: FOLLOWING A CHANGE IN THE MARKET, THE NEW EXTENSIONS REF (B)(4). BD CONNECTA 10 CM ARE NOT COMPATIBLE WITH OUR ACTIVITY, THEY ARE EXTREMELY DIFFICULT TO SCREW IN AND CAUSE LEAKS OF CONTRAST MEDIA. CLINICAL CONSEQUENCES: RISK OF CONTAMINATION OF NURSING STAFF. PRECAUTIONARY MEASURES AND ACTIONS TAKEN: MAIL SENT TO PHARMACY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515688 BD CONNECTA PLUS3 10CM WHITE STOPCOCK, I.V. SET FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 3214536

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown