BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD UNKNOWN CONNECTOR

    MDR report key: 24210456 · Received January 29, 2026

    Report

    Report Number
    9610847-2026-00035
    Event Type
    Malfunction
    Date Received
    January 29, 2026
    Date of Event
    January 4, 2026
    Report Date
    March 5, 2026
    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
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE COMPLAINT OF A LEAK WAS CONFIRMED, AND THE CAUSE APPEARED TO BE MANUFACTURING RELATED. ONE Q-SYTE CONNECTOR FROM LOT #5062596 WAS PROVIDED FOR INVESTIGATION. A FUNCTIONAL TEST REVEALED A LEAK FROM THE Q-SYTE CONNECTOR. AFTER DISASSEMBLING THE CONNECTOR, THE BOTTOM DISC OF THE SEPTUM WAS NOTED TO BE DAMAGED, WHICH WAS LIKELY A CONTRIBUTING FACTOR OF THE REPORTED ISSUE. DUE TO THE INACCESSIBILITY OF THE BOTTOM DISC DURING USE, THE DAMAGE WAS LIKELY CAUSED DURING MANUFACTURING. THE APPROPRIATE MANUFACTURING PERSONNEL WERE NOTIFIED OF THIS COMPLAINT. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY. COMPLAINTS RECEIVED ABOUT 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 DATA COLLECTED FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD UNKNOWN LEAKED. THE NURSE PERFORMED INTRAVENOUS INFUSION. BEFORE USE, SHE INSPECTED THE PRODUCT'S OUTER PACKAGING TO ENSURE IT WAS INTACT AND UNDAMAGED, AND VERIFIED IT WAS WITHIN THE EXPIRATION DATE. AFTER CONNECTING AND OPENING THE INFUSION LINE, THE INTRAVENOUS INFUSION COMMENCED. SHORTLY THEREAFTER, LEAKAGE WAS DETECTED. UPON CAREFUL EXAMINATION, A FINE CRACK WAS DISCOVERED IN THE MAIN BODY OF THE CONNECTOR.

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140423 BD UNKNOWN CONNECTOR STOPCOCK, I.V. SET FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown